Npa 2022-09 v23c Final For Publication

European Union Aviation Safety Agency
Notice of Proposed Amendment 2022-09

in accordance with Article 6(3) of MB Decision No 1-2022
Establishment of a regulatory framework on the

conformity assessment of ATM/ANS systems and
ATM/ANS constituents (ATM/ANS equipment)
RMT.0161 — SUBTASK 1
EXECUTIVE SUMMARY
The objective of the proposals put forward in this Notice of Proposed Amendment (NPA), considering the
technical, scientific and operational needs, is to maintain a high level of safety and to provide for cost-efficient
requirements in the field of ATM/ANS systems and ATM/ANS constituents — i.e. ATM/ANS equipment.
Furthermore, the objective is to meet the relevant security, performance, and interoperability objectives that
would allow the proper functioning of the European Air Traffic Management network (EATMN).
This NPA proposes a regulatory framework for the certification of certain ATM/ANS equipment (i.e. ATM/ANS
systems and ATM/ANS constituents) as well as of organisations involved in its design and/or production once it
has been found to comply with the applicable essential requirements of Regulation (EU) 2018/1139.
The proposed regulatory framework aims to reduce the fragmentation of the ATM/ANS (ground) equipment
market and facilitate industry cooperation at European level. As a result, the application of the proposed
provisions would facilitate the development and implementation of new technologies and speed up the
introduction of new operational concepts that are required in order to increase the capacity of the ATM system
and improve its performance.
ATM/ANS equipment manufacturers would need to apply for and be granted an organisation approval with the
necessary privileges as well as hold ATM/ANS equipment certificates for certain ATM/ANS equipment they
design and/or produce. This would provide for long-term benefits in terms of specifications harmonisation and
a more efficient and flexible use of resources. ATM/ANS providers and similarly their competent authorities will
also benefit from the attestation of certain ATM/ANS equipment by the organisations involved in its design
and/or production, and their responsibilities will be focused on the operational integration of already attested
ATM/ANS equipment.
The proposed new implementing and delegated acts and the amending implementing act are expected to
maintain safety or even marginally increase it through the enhanced commonality and interoperability of the
EATMN while reducing the regulatory burden, increasing cost-effectiveness, and improving harmonisation
among the regulated entities.
Domain: ATM/ANS
Related rules: Annex II (Part-ATM/ANS.AR) and Annex III (Part-ATM/ANS.OR) to Implementing Regulation (EU) 2017/373
Affected stakeholders: ATM/ANS providers; organisations involved in the design and/or production of ATM/ANS systems and
ATM/ANS constituents; national competent authorities (NCAs), including EASA; and where applicable,
aerodrome operators
Driver: Efficiency/proportionality Rulemaking group: Yes
Impact assessment: Yes Consultation: Public
EASA rulemaking procedure milestones
Start Public consultation Proposal to the Adoption by the Decision

Terms of Reference NPA 2022-09 Commission Commission Certification Specifications,
Acceptable Means of Compliance,
EASA Opinion Implementing/Delegated act
Guidance Material
14.2.2020 16.8.2022 2022/Q3 2023/Q3 2023/Q3
TE.RPRO.00034-011 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified.
Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 1 of 82
An agency of the European Union
European Union Aviation Safety Agency NPA 2022-09
Table of contents
Table of contents
1. About this NPA...................................................................................................................... 4
1.1. How this NPA was developed ................................................................................................... 4
1.2. How to comment on this NPA .................................................................................................. 5
1.3. The next steps .......................................................................................................................... 5
2. In summary — why and what ................................................................................................ 6
2.1. Why we need to propose new implementing and delegated acts — issue/rationale ............. 7
2.2. What we want to achieve — objectives ................................................................................... 8
2.3. How we want to achieve it — overview of the proposed implementing and delegated acts . 9
2.3.1. Proposals ......................................................................................................................... 10
2.3.1.1 Draft implementing act (IA) on the approval of organisations involved in the design
and/or production of ATM/ANS equipment ............................................................... 10
2.3.1.2 Draft delegated act (DA) on the certification and declaration scheme for ATM/ANS
equipment ................................................................................................................... 14
2.3.1.3 Draft implementing act amending Implementing Regulation (EU) 2017/373 ............ 19
2.3.2. Maintenance activities .................................................................................................... 21
2.3.3. Transitional provisions .................................................................................................... 22
2.3.4. Other associated deliverables ......................................................................................... 23
2.4. What are the expected benefits and drawbacks of the proposed implementing and
delegated acts?...................................................................................................................... 24
3. Proposed implementing and delegated acts ......................................................................... 25
3.1. Draft regulations (draft EASA opinion) ................................................................................... 25
3.1.1. Draft implementing act laying down technical requirements and administrative
procedures for the approval of organisations involved in the design and/or production of
ATM/ANS systems and ATM/ANS constituents (ATM/ANS equipment) (please refer to
Appendix 1) .................................................................................................................................... 25
3.1.2. Draft delegated act laying down common technical requirements and administrative
procedures for the certification and declaration of compliance of the design of ATM/ANS
systems and ATM/ANS constituents (ATM/ANS equipment) (please refer to Appendix 2) ......... 25
3.1.3. Draft implementing act amending Implementing Regulation (EU) 2017/373 as regards
the conformity assessment of ATM/ANS systems and ATM/ANS constituents (ATM/ANS
equipment) (please refer to Appendix 3) ...................................................................................... 25
4. Impact assessment (IA)........................................................................................................ 26
4.1. What is the issue .................................................................................................................... 26
4.1.1. Safety risk assessment .................................................................................................... 26
4.1.2. Who is affected ............................................................................................................... 26
4.1.3. How could the issue evolve ............................................................................................. 27
4.2. What we want to achieve — objectives ................................................................................. 27
4.3. How we want to achieve it — options ................................................................................... 28
4.4. Methodology and data ........................................................................................................... 29
4.4.1. Methodology applied ...................................................................................................... 29
4.5. What are the impacts ............................................................................................................. 30
4.5.1. Safety impact................................................................................................................... 30
Table of contents
4.5.2. Environmental impact ..................................................................................................... 32

4.5.3. Social impact ................................................................................................................... 32
4.5.4. Economic impact ............................................................................................................. 32
4.5.5. Proportionality issues...................................................................................................... 36
4.6. Conclusion .............................................................................................................................. 37
4.7. Monitoring and evaluation ..................................................................................................... 37
5. Proposed actions to support implementation ...................................................................... 39
6. References .......................................................................................................................... 40
6.1. Related EU regulations ........................................................................................................... 40
6.2. Related EASA decisions .......................................................................................................... 40
6.3. Other references .................................................................................................................... 40
7. Quality of the NPA .............................................................................................................. 41
7.1. The regulatory proposal is of technically good/high quality .................................................. 41
7.2. The text is clear, readable and understandable ..................................................................... 41
7.3. The regulatory proposal is well justified ................................................................................ 41
7.4. The regulatory proposal is fit for purpose (capable of achieving the objectives set) ............ 41
7.5. The impact assessment (IA), as well as its qualitative and quantitative data, is of high
quality .................................................................................................................................... 41
7.6. The regulatory proposal applies the ‘better regulation’ principles ....................................... 41
7.7. Any other comments on the quality of this NPA (please specify) .......................................... 41
8. Appendices ......................................................................................................................... 42
8.1. Appendix 1: DRAFT COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down
technical requirements and administrative procedures for the approval of organisations
involved in the design and/or production of ATM/ANS systems and ATM/ANS constituents
............................................................................................................................................... 42
8.2. Appendix 2: DRAFT COMMISSION DELEGATED REGULATION (EU) …/... laying down common
technical requirements and administrative procedures for the certification and declaration
of compliance of the design of ATM/ANS systems and ATM/ANS constituents................... 53
8.3. Appendix 3: DRAFT COMMISSION IMPLEMENTING REGULATION (EU) …/... amending
Implementing Regulation (EU) 2017/373 as regards the conformity assessment of
ATM/ANS systems and ATM/ANS constituents .................................................................... 79
1. About this NPA
1. About this NPA

1.1. How this NPA was developed
The European Union Aviation Safety Agency (EASA) developed this Notice of Proposed Amendment
(NPA) in the context of Rulemaking Task (RMT).01611, which is included in Volume II of the European
Plan for Aviation Safety (EPAS) for 2022-20262. RMT.0161 has been structured into three subtasks to
clearly describe the work undertaken with this rulemaking activity as follows:
— Subtask 1: Establishment of an EU regulatory framework and amendment of the respective
provisions on the conformity assessment of ATM/ANS systems and ATM/ANS constituents
(ATM/ANS equipment) to contribute to the safety and interoperability of the European ATM
network (EATMN) operation.
— Subtask 2: Review of the Single European Sky (SES) interoperability Regulation (implementing
Regulation (EC) No 552/2004 repealed by Regulation (EU) 2018/11393 (the Basic Regulation)) to
update and adapt it to the EASA regulatory framework.
— Subtask 3: Establishment of the related acceptable means of compliance (AMC) and guidance
material (GM) that support Subtask 1 deliverables and the first set of the EASA detailed
specifications (DSs) based on existing interoperability rules and related Community
specifications4.
The proposal is in line with the Basic Regulation and the Rulemaking Procedure5.
EASA developed this NPA with the support of Rulemaking Group (RMG) RMT.0161 as well as by duly
taking into account the strategic inputs provided by the Steering Group on ATM ground equipment.
It is hereby submitted to all interested parties for consultation in accordance with Article 115 of the
Basic Regulation and Article 6(3) of the Rulemaking Procedure.
The major milestones of this RMT are presented on the cover page.
1 https://www.easa.europa.eu/document-library/terms-of-reference-and-group-compositions/tor-rmt0161
2 European Plan for Aviation Safety 2022 - 2026 | EASA (europa.eu)
3 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of
civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005,
(EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European
Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European
Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1) (https://eur-
lex.europa.eu/legal-content/EN/TXT/?qid=1535612134845&uri=CELEX:32018R1139).
4 Community specifications (europa.eu)
5 EASA is bound to follow a structured rulemaking process as required by Article 115(1) of Regulation (EU) 2018/1139.
Such a process has been adopted by the EASA Management Board (MB) and is referred to as the ‘Rulemaking Procedure’.
See MB Decision No 01-2022 of 2 May on the procedure to be applied by EASA for the issuing of opinions, certification
specifications and other detailed specifications, acceptable means of compliance and guidance material (‘Rulemaking
Procedure’), and repealing Management Board Decision No 18-2015 (https://www.easa.europa.eu/downloads/136443/en).
1. About this NPA
1.2. How to comment on this NPA

Please submit your comments using the automated Comment-Response Tool (CRT) available at
http://hub.easa.europa.eu/crt/6.
The deadline for the submission of comments is 30 September 2022.
1.3. The next steps
Following the public consultation period, EASA will review and analyse all the comments received,
further revise the proposed regulatory proposal, as appropriate, and issue an opinion. In this context,
EASA might perform focused consultation activities to discuss and address specific issues, as deemed
appropriate, for which the stakeholders’ views are considered essential or require further evaluation.
Together with the opinion, EASA will also publish a comment-response document (CRD)7 that will
contain all the comments received during the public consultation of the NPA.
The opinion shall be issued and addressed to the European Commission, which will use it as a technical
basis to consider the adoption of the proposed implementing and delegated acts.
Upon adoption by the European Commission of the implementing and delegated acts proposed with
the opinion, EASA will issue a decision with the first set of the related detailed
(certification/declaration) specifications (CSs/DSs), acceptable means of compliance (AMC) and
guidance material (GM) which can be used by organisations involved in the design and/or production
of ATM/ANS equipment for the purpose of certification and demonstration of compliance in terms of
safety, interoperability, and performance. Before the publication of such decision, the related
proposed CSs/DSs/AMC/GM will be publicly consulted through a dedicated NPA (as defined for
Subtask 3 of RMT.0161).
6 In case of technical problems, please send an email to crt@easa.europa.eu with a short description.
7 https://www.easa.europa.eu/document-library/comment-response-documents
2. In summary — why and what

The Single European Sky (SES) initiative was launched in 2004 with the aim to improve the
performance of the European ATM system in terms of safety, capacity, cost-efficiency, and
environmental compatibility. These elements remain as valid today as they were back then. Stressing
the importance of that aim, it is acknowledged that the effective introduction of new technologies
plays a crucial role in ensuring that the future ATM system will continue to efficiently support air
traffic, including new categories of airspace users such as drones. Besides, ATM/ANS will increasingly
rely on digital technologies and automation, and the attestation of the related ATM/ANS equipment
will require very specialised capabilities both for industry actors and competent authorities.
In this context, the following is considered ‘ATM/ANS equipment’:
— ATM/ANS systems (excluding airborne constituents), and
— ATM/ANS constituents.
The 2019 Report of the Wise Persons Group on the Future of the Single European Sky8 acknowledged
the challenge in terms of seamless interoperability and network efficiency for the European ATM
system that results from the variety of national ATM/ANS systems operated by national air navigation
service providers (ANSPs).
The Basic Regulation lays down interoperability requirements for the European Air Traffic
Management network (EATMN) and mandates the development of the related delegated and
implementing acts as regards the certification or declaration of ATM/ANS systems and ATM/ANS
constituents as well as of the organisations involved in their design, production, and maintenance.
At the same time, Regulation (EC) No 552/20049 (the interoperability Regulation) was repealed by the
Basic Regulation, but Article 139 of the Basic Regulation establishes the transitional provisions
whereby certain articles of the interoperability Regulation and its annexes remain applicable until the
date of application of the related delegated acts and insofar as those acts cover the subject matter of
the relevant provisions of the interoperability Regulation, and in any case not later than 12 September
2023.
In this context, it is necessary to introduce a new regulatory framework in relation to ATM/ANS
systems and ATM/ANS constituents (referred to as ‘ATM/ANS equipment’) that ensures the safe,
interoperable, and efficient provision of ATM/ANS services. The new regulatory framework proposed
with this NPA would enable the certification/declaration of certain ATM/ANS equipment as well as of
the organisations involved in their design, production, and maintenance once they have been found
to comply with the applicable essential requirements of the Basic Regulation.
Accordingly, it will introduce the necessary detailed requirements for the issue of the certificates for
certain safety-critical ATM/ANS equipment and for the declarations to be made for other ATM/ANS
equipment. Such requirements are proposed considering the objectives of the Basic Regulation as well
as the nature and risk of the particular activity where ATM/ANS equipment is involved.
8 https://www.sesarju.eu/sites/default/files/documents/reports/report-wise-persons-group-future-ses.pdf
9 Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of
the European Air Traffic Management network (the interoperability Regulation) (OJ L 96, 31.3.2004, p. 26) (https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32004R0552&qid=1657106139572).
The requirements proposed with this NPA establish the criteria and conditions to determine the need
for certification or for declaration of certain ATM/ANS equipment based on its safety criticality and
benefits for the relevant stakeholders. They also address the oversight of organisations involved in the
design, production, and maintenance of the ATM/ANS equipment in question.
2.1. Why we need to propose new implementing and delegated acts — issue/rationale
The SES Interoperability framework did not explicitly regulate organisations involved in the design
and/or production of ATM/ANS equipment; they were indirectly affected by those requirements for
ATM/ANS providers that make use of that equipment. Subsequently, the responsibilities of the various
parties involved in the ATM/ANS equipment conformity assessment process, and particularly of the
various parties involved and their oversight, were not clearly defined and thus their oversight was not
performed in a standardised and consistent manner.
With the repeal of the interoperability Regulation, point 2 of Article 140 ‘Transitional provisions’ of
the Basic Regulation requires that not later than 12 September 2023 the implementing rules adopted
on the basis of Regulations (EC) No 216/2008 and (EC) No 552/2004 shall be adapted to the Basic
Regulation. In this context, the establishment of a new conformity assessment framework has been
considered by means of delegated and implementing acts by the referenced date. This initiative offers
a unique opportunity to address all shortcomings of the previous framework, which are summarised
in the following paragraphs.
The SES Interoperability framework allocated the responsibilities for the conformity assessment in a
manner that has resulted in a lack of level playing field, with differing arrangements between the
regulated entities (national competent authorities, ANSPs, and manufacturers) across Europe. Based
on implementation feedback, this has caused also unnecessary complexity and economic burden for
manufacturers as well as for ATM/ANS providers, and it does not facilitate the coordinated
introduction of new, agreed, and validated concepts of operation and technologies.
The prevalence of national technical specifications used in procurement has led to the fragmentation
of the ATM/ANS ground equipment market and does not facilitate industry cooperation at European
Union level. As a result, the manufacturing industry is negatively affected since it needs to adapt its
products to various national markets; these practices render the development and implementation of
new technologies unnecessarily difficult and slow down the introduction of new operational concepts
that are required to increase the capacity of the ATM system and improve its performance.
Article 45 of the Basic Regulation stipulates that, where the related delegated acts so provide,
ATM/ANS systems and ATM/ANS constituents shall be subject to certification and shall be issued with
a certificate, or be subject to declaration by the organisation involved in their design and/or
production.
In order to address the above-mentioned lack of harmonisation, this NPA introduces the certification
and declaration scheme for certain ATM/ANS equipment, considering the objectives of the Basic
Regulation and the nature and risk of the particular activity.
In addition, the SES Interoperability Regulation has put the onus for the conformity assessment on
ATM/ANS providers, only indirectly addressing the organisations involved in the manufacturing of
ATM/ANS equipment. Although the mitigation of the safety risks is ultimately the responsibility of the
ATM/ANS service providers that use ATM/ANS equipment, the contribution of the organisations that
are directly involved also in the design and manufacturing of such ATM/ANS equipment needs to be
adequately addressed. This proposal systematises the processes to ensure that responsibilities linked
to design and/or production are appropriately discharged when the criticality of the ATM/ANS
equipment so requires. This would allow applying processes whose efficiency has been demonstrated
for decades in the field of airworthiness, similar but not identical to those used for aircraft
modifications and aircraft parts and appliances, thereby facilitating the work of the ATM/ANS
providers and reducing costs related to ATM/ANS equipment that can be standardised in terms of
performance and functions.
Moreover, the framework established by the SES Interoperability Regulation did not provide the
necessary clarity as regards the requirements such ATM/ANS equipment must fulfil; in particular, it
did not specify the criteria against which the declarations (verification of systems, and constituent
conformity or suitability for use) had to be issued. On the contrary, the new regulatory framework on
ATM/ANS equipment aims to provide the manufacturers concerned and ATM/ANS providers with the
necessary legal certainty.
As regards verification of compliance with the essential requirements of the Basic Regulation, EASA
aims to adequately allocate the responsibilities of the various affected stakeholders along the
ATM/ANS equipment life cycle, thus providing for legal clarity and allowing swifter and more efficient
compliance assessment processes. At the same time, this improved allocation of responsibilities would
facilitate the planning of the necessary capabilities by the different stakeholders.
2.2. What we want to achieve — objectives

The overall objectives of the EASA system are defined in Article 1 of the Basic Regulation and are
complemented by Article 4, in which several principles are established. The proposals of this NPA will
contribute to achieving the overall objectives by addressing the issues described in Section 2.1.
Additionally, the proposed regulatory framework will ensure that the relevant safety, security,
performance, and interoperability objectives are met by supporting the efficient functioning of the
EATMN, in compliance with the applicable requirements of the Basic Regulation and of the delegated
and implementing acts adopted on its basis.
In this context, the specific objectives are to:
— minimise any undesirable implementation issues that may compromise operational
functionalities, and promote technical interoperability by using detailed specifications;
— promote the development of the internal market by ensuring fair competition while facilitating
the free movement of ATM/ANS equipment through the mutual recognition of certificates or
declarations, without further requirements or evaluation, in all Member States;
— facilitate the development and implementation of new technologies in the ATM/ANS sector;
— enable increased efficiency and reduced costs as regards the procurement and maintenance of
ATM systems, as well as improved operational coordination for the attestation process;
— optimise the use of resources during the demonstration of compliance and minimise the
administrative burden; and
— maximise the synergies with existing processes to introduce changes to ATM/ANS functional
systems resulting from the deployment of new or updated ATM/ANS equipment.
2.3. How we want to achieve it — overview of the proposed implementing and

delegated acts
To achieve the objectives described in Section 2.2, it is proposed to develop a single, harmonised and
mutually recognised mechanism to attest compliance of certain ATM/ANS equipment based on its
intended use for the safe, interoperable, and efficient operation of the EATMN for all phases of flight.
The proposed new framework is expected to address identified weaknesses of the current approach,
including the following:
— limited technical harmonisation and its voluntary application;
— limited, or even a lack of, oversight in the design and/or production of ATM/ANS equipment;
— a variety in the maturity of compliance demonstration across the Member States leading to
different interpretation of the approach and evidence required to support such process;
— application of the ‘one-size-fits-all’ approach whereby ATM/ANS providers and ATM/ANS
equipment manufacturers are required to follow the same attestation process (issue of EC
declarations) for all ATM/ANS systems and constituents, without considering the risk and the
safety criticality of that particular activity (i.e. the functions performed by the ATM/ANS
equipment).
The proposal would enable a holistic, end-to-end and performance-based approach as regards the
attestation of ATM/ANS equipment (as illustrated in Figure 1 below), facilitating the provision of
ATM/ANS services in Europe as it will address the various phases of the life cycle of ATM/ANS
equipment.
Figure 1
2.3.1. Proposals
This NPA proposes the introduction of a new EU regulatory framework for the conformity assessment
of ATM/ANS equipment in order to contribute to the improvement of the safety and interoperability
of the EATMN operation. The proposal is structured as follows:
— a new implementing act (IA) laying down requirements on the approval of organisations
involved in the design and/or production of ATM/ANS equipment (hereinafter referred to as
‘ATM/ANS equipment manufacturers’);
— a new delegated act (DA) on an attestation scheme for ATM/ANS equipment; in this context, it
should be noted that the new framework will provide three different instruments as a means
of attestation, namely: certification, declaration, and statement of compliance; and
— the necessary amendments proposed to Implementing Regulation (EU) 2017/37310 with the
objective to implement a total system approach and ATM/ANS equipment end-to-end
performance.
2.3.1.1 Draft implementing act (IA) on the approval of organisations involved in the design and/or
production of ATM/ANS equipment
In accordance with the provisions of the Basic Regulation, this proposal introduces a scheme according
to which organisations that are involved in the design and/or production of ATM/ANS equipment are
required to demonstrate the capability to carry out their activities. This scheme shall be based on the
issuance of an organisation approval specifying the privileges granted to organisations involved in the
design and/or production of ATM/ANS equipment.
This draft implementing act (IA) proposes the requirements for the approval of organisations involved
in the design and/or production of ATM/ANS systems and ATM/ANS constituents (i.e. ATM/ANS
equipment).
The typical life cycle of ATM/ANS equipment consists of various phases, i.e. design, production,
installation, operation, and maintainance. Some of these phases are usually performed by the
ATM/ANS provider, while others are undertaken by the organisations involved in the design and/or
production of ATM/ANS equipment.
In the context of this regulatory proposal, the technical requirements and the procedures for the
approval are intended to reflect a single set of privileges in the area of design and production of
ATM/ANS equipment.
The ATM/ANS equipment design and/or production responsibilities covered under the organisation
approval would comprise the following:
— identification of the functional requirements for ATM/ANS equipment;
10 Commission Implementing Regulation (EU) 2017/373 of 1 March 2017 laying down common requirements for providers
of air traffic management/air navigation services and other air traffic management network functions and their oversight,
repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No 1034/2011, (EU) No 1035/2011 and (EU)
2016/1377 and amending Regulation (EU) No 677/2011 (OJ L 62, 8.3.2017, p. 1) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32017R0373&qid=1657185766802).
— definition of the technical requirements;

— detailed architectural design;
— definition of the processes and methods for manufacture and assembly;
— manufacture in accordance with design documentation;
— preparation and update of complete technical documentation and records; and
— preparation and update of all required manuals to be provided with the equipment.
Installation and maintenance/operation are considered ATM/ANS provider responsibilities (as defined
in Implementing Regulation (EU) 2017/373), and thus already covered under the ATM/ANS provider
certificate. Regarding those activities that are closer to the interface between ATM/ANS equipment
manufacturer and ATM/ANS provider, recurrent maintenance is considered part of the ATM/ANS
provider activities, while evolutive maintenance is considered typically a design and production
function under the responsibility of the ATM/ANS equipment manufacturer.
Figure 2
An organisation approval would be required for organisations involved in the design and/or
production of ATM/ANS equipment when the ATM/ANS equipment is subject to certification or
declaration. Only an approved organisation would be entitled to apply for the certification of
ATM/ANS equipment, or declare compliance of the design with detailed declaration specifications
(DSs).
ATM/ANS equipment manufacturers, i.e. organisations involved in the design and/or production of
ATM/ANS equipment, are those primarily affected by the proposed new regulatory framework.
The proposal structures the processes in such a way to ensure that the responsibilities linked to design
and production are appropriately discharged.
ATM/ANS providers will remain responsible for the maintenance of the equipment11 and for
operational tasks, as it is the case today (‘business as usual’), but for the most critical ATM/ANS
equipment they will be relieved of the responsibility to consolidate the conformity assessment work
and attest the equipment. Their focus will be on the operational integration of ATM/ANS equipment
after receiving the ATM/ANS equipment attestation from the organisation involved in its design
and/or production. Similarly, the responsible competent authorities of the ATM/ANS service providers
could focus their respective efforts on overseeing the integration and entry into service of the
ATM/ANS equipment12.
Consequently, manufacturers would be required to demonstrate their capability associated with the
design and/or production of certain ATM/ANS equipment, when so prescribed in the implementing
acts. This does not imply that manufacturers (organisations) should be systematically regulated in
order to relieve the responsibility of ATM/ANS providers with regard to ATM/ANS equipment
manufacturers that produce equipment, but only in those cases where this would add value on the
level of the overall system. Examples of cases where they would be required to be regulated is for
ATM/ANS equipment considered essential for the deployment of certain Single European Sky ATM
Research (SESAR) projects. In this context, organisations involved in the design and/or production of
ATM/ANS equipment will be required to establish and maintain a management system in order to
manage their activities and achieve their objectives. The management system establishes the policy
and objectives, and defines the structure, processes and resources needed to achieve those
objectives. It is anticipated that an ATM/ANS equipment manufacturer management system will
contain items such as the following:
— the overall philosophies and principles of the design and production organisation (DPO);
— the lines of responsibility and accountability throughout the organisation, including the direct
accountability of accountable managers;
— processes for:
— compliance monitoring with the applicable requirements including a feedback system to
the accountable manager to ensure effective implementation of corrective actions;
— verification of the performance of the DPO in light of the performance indicators and
performance targets of the management system;
— identification of changes within the DPO which may affect established processes,
procedures and products, and where necessary modify the management system to
accommodate those changes;
— communication to ensure that all DPO staff are fully aware of the management system;
11 For further details, please refer to Section 2.3.2.

12 For further details, please refer to Section 2.3.1.3.
— identification of the scope of changes to the design and production of ATM/ANS

equipment and the associated risk;
— the design and production, and changes, including:
• ensuring compliance with the applicable specifications,
• an independent checking function, and
• production control procedures;
— the verification of the acceptability of GE and of (any) tasks performed by contracted

organisations;
— ensuring that sufficient numbers of experienced staff are involved in the design and
production, and have been made aware of their responsibilities, and authorised to
discharge their allocated responsibilities;
— coordination within departments and between departments.
The proposal considers EASA to act as the competent authority for the approval of organisations
involved in the design and/or production of ATM/ANS equipment as well as for the certification of,
and the receipt of declarations for, ATM/ANS equipment (as further explained in Section 2.3.1.2).
According to Article 80(1)(c) of the Basic Regulation, EASA is responsible for the certification of
organisations involved in the design, production, or maintenance of ATM/ANS systems and ATM/ANS
constituents, including where they contribute to the Single European Sky ATM Research (SESAR)
implementation, used in the provision of the services referred to in Article 80(1)(b), meaning pan-
European ATM/ANS (provided by ATM/ANS providers certified by EASA).
As the objective of the Basic Regulation is to promote cost-efficiency by, among others, avoiding
duplication, and promoting effectiveness in the regulatory, certification and oversight processes, as
well as making efficient use of the related resources at Union and national level, point (c) of
Article 80(1) of the Basic Regulation is to be read together with the regulatory solution proposed for
the certification and declaration of ATM/ANS systems and ATM/ANS constituents. In this respect, this
proposal addresses the responsibilities of organisations involved in the design and/or production of
ATM/ANS equipment, after carefully considering the following aspects:
— Before the ATM/ANS equipment is designed or produced, it is impossible to determine upfront
how it will be used afterwards when it is to be put into service by an ATM/ANS provider, i.e.
whether it will be used solely for the provision of ATM/ANS services within the national airspace
of a Member State, or also for cross-border employment in the national airspace of most or all
Member States. EASA considers that the future regulatory system should allow for any
ATM/ANS equipment designed or produced in the EU to be potentially used also for the
provision of pan-European ATM/ANS services; thus, it would require prior EASA approval.
— As regards the framework, the need should also be avoided for an organisation involved in the
design and/or production of ATM/ANS equipment to hold several approvals — one issued by a
national authority and one by EASA, for exactly the same type of activity only because certain
equipment designed and/or produced by that organisation would be used for the provision of
ATM/ANS services within the national airspace of a Member State, while some other pieces of
ATM/ANS equipment for the provision of pan-European ATM/ANS. Such situation would create
unnecessary and costly duplication and administrative burden mainly for organisations involved
in the design and/or production of ATM/ANS equipment and their authorities provided that the
requirements for design/production are the same irrespective of the way the ATM/ANS
equipment will be used afterwards.
— Furthermore, as described in Section 2.3.1.2 and in accordance with Article 80(2) of the Basic
Regulation, EASA is responsible for all competent authority tasks related to certificates and
declarations for ATM/ANS systems and ATM/ANS constituents (i.e. ATM/ANS equipment).
To avoid significant complications, the responsibilities for the approval and oversight of
organisations involved in the design and/or production of ATM/ANS equipment, which are the
ones entitled to apply for the certification or the issue of declarations for the ATM/ANS
equipment, should be allocated consistently with those responsibilities related to the
certification of, and receipt of declarations for and oversight of, that ATM/ANS equipment.
Theoretically, there could still be organisations whose business plan would be to design and/or
produce critical ATM/ANS equipment (subject to certification or declaration) and market it exclusively
for the provision of ATM/ANS at national level. However, today, this case is not representative of the
European ATM/ANS equipment market and the current digitalisation trends make it even less likely in
the future. In this regard, this proposal builds on the exclusive competence of EASA to approve design
and production organisations in order to avoid duplication, promote efficiency and effectiveness of
the certification and oversight processes, thus resulting in an efficient use of resources at Union and
national level.
This would allow to apply a similar approach whose efficiency has been demonstrated for decades in
the field of airworthiness. Similarly, EASA would develop the relevant staff resources to ensure the
initial approval and continuing oversight of organisations involved in the design and/or production of
ATM/ANS equipment.
In addition to the considerations above, it has to be noted that a definition of ‘pan-European
ATM/ANS’ is not provided in the Basic Regulation, but is stipulated on the level of an implementing
act: Article 2(4) of Implementing Regulation (EU) 2017/373 defines ‘pan-European ATM/ANS’ as ‘an
activity which is designed and established for users within most or all Member States and which may
also extend beyond the airspace of the territory to which the Treaty applies’. Due to the fact that the
term ‘pan-European ATM/ANS’ was developed and defined before the entry into force of the Basic
Regulation, it does not adequately reflect the nature, the objectives, and the risks of the services
whose provision is supported by the employment of ATM/ANS equipment and by its proposed
certification according to the new scheme proposed by this NPA. Subsequently, EASA is of the opinion
that the aforementioned definition needs to be further clarified to better scope the area in which such
pan-European ATM/ANS services are provided in relation to the approval and oversight of
organisations involved in the design and/or production of ATM/ANS equipment.
2.3.1.2 Draft delegated act (DA) on the certification and declaration scheme for ATM/ANS
equipment
The draft delegated act establishes the new framework on the conformity assessment of certain
ATM/ANS equipment that should be proportionate to the risks involved, making use of existing
methodologies and best practices. Thus, the new framework establishes three possible instruments
based on the principles established by the Basic Regulation:
— certification by EASA of certain safety-critical ATM/ANS equipment based on detailed
certification specifications adopted by EASA (Article 4).
— declaration by an approved organisation involved in the design and/or production of ATM/ANS
equipment for other critical ATM/ANS equipment based on detailed declaration specifications
adopted by EASA (Article 5); and
— statement of compliance by the ATM/ANS provider for all other ATM/ANS equipment
(Article 6); this approach constitutes a similar approach to the current EC declarations scheme
based on the interoperability Regulation.
The draft delegated act defines the criteria against which the certification of or declaration for the
ATM/ANS equipment is respectively required, considering the nature and the risk of a particular
operation or functionality. Where certification or declaration is required, this will be based on the
demonstration of compliance with the relevant detailed certification/declaration specifications, which
is the novelty to be introduced in accordance with Article 47(1)(a) of the Basic Regulation. The draft
delegated act (in particular its point ATM/ANS.EQMT.AR.A.040 Detailed specifications for the
certification and declaration of design compliance) lays down the requirements for the establishment
of the criteria that shall be sufficiently detailed and specific so that they may be used by applicants
and/or approved organisations to demonstrate compliance with the relevant essential requirements
set out in Annex VIII and, if applicable, Annex VII to the Basic Regulation.
In this context, it should be highlighted that the interoperability Regulation had identified a list of
systems, their constituents, and associated procedures, to which the interoperability framework
applied. Therefore, to promote innovation and avoid constraints, it is considered essential to specify
the scope and definition of the ATM/ANS equipment subject to certification at EU regulation level,
and the particularities and the specific ATM/ANS equipment listed at detailed specification and AMC
level. This approach takes into account the related recommendation of the CNS Advisory Group.
It is anticipated that, when developing the detailed specifications for ATM/ANS equipment, EASA may
decide to refer to widely recognised international standards published by industry, through standards
development organisations (SDOs), to be used as a means of compliance in accordance with
Article 1(3)(d) of the Basic Regulation.
This attestation scheme would enable the full coverage and effective oversight of ATM/ANS
equipment in a standardised manner while promoting and enabling the development and
implementation of new technologies with clear responsibilities established for each of the actors
involved (i.e. organisations involved in the design and/or production of ATM/ANS equipment,
ATM/ANS providers as customers and users, as well as national competent authorities and EASA
responsible for the oversight of ATM/ANS providers).
Article 3 defines EASA as the competent authority for certification, oversight, and enforcement in
accordance with Article 62(2) of the Basic Regulation with respect to certificates, and declarations
issued by approved organisations, for ATM/ANS equipment, and following the principles laid down in
Article 80(2) of the Basic Regulation.
Following this principle, Article 4 scopes the ATM/ANS equipment subject to certification. While
recognising that to date no significant safety issues have been identified in relation to the operation
of ATM ground equipment in the EATMN, it should be noted that the provision of ATM/ANS is highly
influenced by a considerable degree of redundancy and number of mitigating measures (e.g. safety
barriers) put in place.
The forecast evolution of the ATM/ANS landscape, necessary to fulfil the performance and user
requirements, will increase the safety and security criticality of key EATMN elements. This is the case
especially for ATM/ANS equipment employed for the processing and integration of data for onward
transmission and direct use for the purpose of safe and interoperable EATMN operations, in particular
encompassing certain air traffic services (ATS) functionalities (trajectory management, collision
avoidance, separation management, aerodrome situational awareness, surface guidance and routing,
air traffic flow management, voice communications). Therefore, such ATM/ANS equipment is
proposed to be subject to certification by EASA once compliance with a detailed certification
specification has been demonstrated by an approved organisation involved in the design and/or
production of ATM/ANS equipment. The certificates shall be valid and recognised in all Member States
without any further requirements or technical evaluation.
There are several reasons why this cluster has been considered the most critical equipment in terms
of interoperability and safety impact:
— The processing and delivery of data to support real-time operational functions is key for the
functioning of the ATM system. Strategic reflection has indicated that the effective free flow of
data among interoperable ATM/ANS systems is the key enabler for the required resilience,
flexibility, and scalability of the ATM/ANS system — since the digitalisation of Europe’s aviation
infrastructure is a key element of Europe’s strategy on a single digital market.
— The full interoperability of the main functions in the data layer can only be optimally achieved
through the application of common specifications. Furthermore, a centralised approach is
highly recommended due to the fact that appropriate attestation and oversight require very
specialised knowledge.
— The interoperability and safety criticality of the functions with regard to processing and
delivering data for operations will become more reliable only through the further automation
of the ATM system in the coming decades, in particular considering the forecast air traffic
growth and the increasing operational complexity through the integration of new airspace users
(e.g. unmanned aircraft systems (UASs), higher-airspace operations (HAOs)).
Examples of ATM/ANS equipment that would be subject to certification are the following:
— flight data processing systems;
— surveillance data processing systems;
— central ATFM systems; and
— certain integration of these systems (e.g. remote tower system).
While not providing for the same level of safety or interoperability criticality as the ATM/ANS
equipment subject to certification, the impact of certain ATM/ANS equipment in terms of EATMN
interoperability is important. Therefore, Article 5 defines that ATM/ANS equipment shall be subjected
to declaration by an approved organisation involved in the design and/or production of ATM/ANS
equipment based on detailed declaration specifications adopted by EASA. It is proposed that

ATM/ANS equipment that generates, transmits and receives data and/or signals in space for the
purpose of safe and interoperable air navigation be attested through a declaration by an organisation
involved in the design and/or production of that ATM/ANS equipment. COM/NAV/SUR sensors,
transceivers and aids are well specified (e.g. at ICAO level), and the declaration by an approved
organisation would be the most proportionate means to ensure the necessary ATM/ANS equipment
safety and interoperability. Examples of ATM/ANS equipment for which declaration is the proposed
approach include the following:
— GBAS,
— conventional NAV AIDS: e.g. ILS, VOR, NDB, etc.,
— SUR sensors: ADS-B, MODE-S radar, etc.
Considering the importance of the subject, EASA wishes to seek stakeholders’ views on the inclusion
of the equipment used for surveillance within the scope of the equipment subject to declaration.
Stakeholders are invited to comment whether sensors (for example, PSR/SSR radars, ADS-B receivers
or MLAT equipment) which are used for surveillance should be subjected to declaration by approved
ATM/ANS equipment manufacturers, including a justification.
Furthermore, these ATM/ANS equipment manufacturers shall submit the referenced ATM/ANS
equipment declarations to EASA as the competent authority for their registration and oversight. These
declarations shall be valid and recognised in all Member States without any further technical
requirements or evaluation.
It shall be noted that the implementation of Article 4 ‘Certification of ATM/ANS equipment’ and
Article 5 ‘Declaration of ATM/ANS equipment’ could be performed only with the availability of
accompanying EASA measures (i.e. detailed specifications (DSs) and associated acceptable means of
compliance (AMC) and guidance material (GM)).
For this purpose, EASA will develop and consult by means of an NPA the first set of the detailed
certification/declaration specifications and the associated draft AMC and GM in due time with the aim
of publishing them via the issue of an EASA Decision concurrently with the adoption of the proposed
implementing and delegated acts. For further details, please refer to Section 2.3.4.
Article 6 introduces the third instrument for the attestation of ATM/ANS equipment: the statement
of compliance (SoC) issued by ATM/ANS providers. It is considered crucial that ATM/ANS providers
continue to verify certain ATM/ANS equipment attesting that it complies with the technical standards
established by recognised standardisation bodies and listed in detailed specifications (i.e. for that
ATM/ANS equipment not required to be certified nor declared by organisations involved in its design
and/or production), which is to be put into operation and used for the provision of their services. This
approach is similar to the current method of declaration of verification (DoV).
The essential requirements as regards ATM/ANS equipment laid down in the Basic Regulation are
similar in terms of nature and granularity to those of the repealed interoperability Regulation.
However, it is necessary to detail how compliance of the currently deployed ATM/ANS equipment that
will be subjected to certification or declaration under the new scheme will be ensured.
Article 7 ‘Transitional provisions’ contains the necessary transitional measures for the introduction
of the new framework which stipulates that ATM/ANS equipment already deployed would not
negatively affect the intended objectives or would represent any regression from the current safety
and interoperability levels. Considering the three instruments (i.e. certification, declaration, and
statement of compliance) being introduced as a means of attestation, the transitional provisions
would only be relevant for ATM/ANS equipment subject to certification and declaration under the
new regulatory framework.
Two groups of transitional measures are proposed, addressing respectively:
— equipment that holds an EC Declaration of Verification (DoV), pursuant to Regulation (EC)
No 552/2004, issued until 12 September 2023; and
— equipment manufactured or put into operation after 12 September 2023, but before all the
building blocks of the new regulatory framework are in place.
For equipment that holds an EC Declaration of Verification (DoV), the envisaged approach is to treat
it from 13 September 2023 as provisionally meeting the requirements of the new regulatory
framework, without any additional requirements for the ATM/ANS providers that operate that
equipment.
With regard to ATM/ANS equipment subject to certification/declaration, EASA will be required to
perform an evaluation of its compliance within a defined period (e.g. 5 years). For that purpose, the
competent authorities responsible for the certification and oversight of ATM/ANS providers (i.e. those
to which the EC Declaration of Verification (DoV) and the Technical Files have been submitted
pursuant to Regulation (EC) No 552/2004) will be required to provide EASA with the relevant
information to facilitate this evaluation. Following that evaluation, EASA should conclude whether the
applicable essential requirements of the Basic Regulation and the corresponding delegated and
implementing acts are met, and in case any non-compliance is identified, appropriate action is taken.
As regards ATM/ANS equipment that falls within the category of ATM/ANS equipment subject to a
statement of compliance issued by the ATM/ANS provider, the EC DoV of the systems that has been
issued or recognised will continue to be valid and shall be considered a statement of compliance under
the new regulatory framework.
For ATM/ANS equipment manufactured or put into operation during the transitional period, there
is a need to differentiate between the different attestation methods (i.e. certification, declaration, or
statement of compliance). As from 13 September 2023, the new framework will require ATM/ANS
providers to issue a statement of compliance for the ATM/ANS equipment being deployed and subject
to the new framework during this transitional period. The introduction and the full implementation of
the certification and declaration scheme would require time for the regulated parties, including EASA,
to set up all the necessary enablers for the functioning of the new regulatory framework (e.g. granting
approvals to organisations involved in the design and/or production of ATM/ANS equipment, adoption
of certification/declaration/detailed specifications for ATM/ANS equipment); consequently, the
transitional provisions take into account some of the building blocks of the new framework that
require time to be implemented: e.g. between 1 to 3 years might be needed for the approval of the
organisations involved in the design and/or production of ATM/ANS equipment following the
adoption of the new regulatory framework. In addition, when defining the transitional period, the fact
is acknowledged that applicants will need time to demonstrate that the deployed ATM/ANS
equipment complies with the certification/declaration specifications. In this regard, the approach
being considered is based on the deferred application of the requirements related to certification or
declaration. Those requirements will only become applicable after a certain number of years, which
may be the same period of 5 years as in the case of equipment that holds an EC DoV, aiming for
simplicity. This would allow for the adequate and necessary preparation of the industry concerned.
2.3.1.3 Draft implementing act amending Implementing Regulation (EU) 2017/373
For the most critical ATM/ANS equipment in terms of safety, performance and interoperability,
certification will be the mandated attestation method. Declaration will be the method mandated for
an intermediate layer in terms of criticality. Considering the SES IOP framework, in these two cases of
certification and declaration of ATM/ANS equipment, the ATM/ANS provider is relieved of the
responsibility to perform the conformity assessment and attest the equipment and the responsibility
is delegated to the design and/or production organisation. Additionally, oversight responsibilities will
be placed with EASA, while within the SES IOP framework the oversight responsibilities were not
clearly defined but remained within the scope of the NSAs’ activities when overseeing the provision
of ATM/ANS services.
In the case of the third attestation method (i.e. Statement of Compliance), oversight responsibilities
will lie with the competent authority responsible for the oversight of the provision of ATM/ANS
services, i.e. NSAs, or EASA in the case of pan-European or third-country ATM/ANS providers. The new
framework will ensure a better link between the oversight of the conformity assessment activities and
the use of the generated evidence in the context of the review of changes to the functional systems
of the ATM/ANS providers, ensuring a seamless information exchange and cooperation of the relevant
competent authorities using the tools of the EASA system.
In order to ensure regulatory consistency of the new framework with the existing implementing acts,
as well as to ensure a total system approach and to address end-to-end performance of the deployed
ATM/ANS equipment, amendments to Implementing Regulation (EU) 2017/373 are also proposed
with this NPA.
As explained in Section 2.3.1.1, ATM/ANS providers will remain responsible for the maintenance of
the ATM/ANS equipment they deploy and for the related operational tasks as is currently the case
(‘business as usual’) with the focus on the operational integration of the ATM/ANS equipment. Thus,
ATM/ANS providers that will deploy certain ATM/ANS equipment will benefit from the
certification/declaration of the ATM/ANS equipment. Similarly, the responsible competent authorities
of the ATM/ANS providers could focus their respective efforts on overseeing the integration and entry
into service of the ATM/ANS equipment.
Approval of a change to a functional system versus attestation of ATM/ANS equipment
Point 56 of Annex I (Part-DEFINITIONS) to Regulation (EU) 2017/373 defines ‘functional system’ as
‘a combination of procedures, human resources, and equipment, including hardware and software,
organised to perform a function within the context of ATM/ANS and other ATM network functions’.
In this context, it should be highlighted that the proposal on the attestation of ATM/ANS equipment
aims to address the demonstration of compliance of the ATM/ANS equipment with the detailed
specifications to ensure compliance with the essential requirements of the Basic Regulation. In other
words, the draft delegated act addresses demonstration of compliance only on the level of
‘equipment, including hardware and software’, while the changes to the functional system address
demonstration of compliance at system level, which is part of the amendments proposed to
Implementing Regulation (EU) 2017/373.
Figure 3
2.3.2. Maintenance activities
Maintenance is commonly understood as the act of keeping equipment in good condition by making
repairs, correcting problems, etc. However, it could also be understood to refer to changes to
equipment to reflect developments in requirements and standards. In order to cover these two
potentially different meanings, the subject proposal differentiates routine maintenance from
upgrades/evolution of existing equipment due to functional changes.
Routine maintenance is considered the performance of those tasks that are necessary to ensure that
ATM/ANS equipment can continue to operate correctly to fulfil its operational function. The principles
of the new conformity assessment framework will result in that this type of maintenance (i.e. routine
maintenance) should only be performed in accordance with the instructions, guidance and
requirements provided by the organisations involved in the design and/or production of ATM/ANS
equipment in order to ensure the validity of the certificate or declaration of the particular ATM/ANS
equipment. Such routine maintenance activities would be normally within the remit of ATM/ANS
providers which perform them in accordance with the instructions of the relevant ATM/ANS
equipment manufacturer.
Equipment upgrade is normally associated with a change to the functions, including the methods and
the technology used. These changes/upgrades might affect the demonstration of compliance of the
ATM/ANS equipment with its certification basis and, therefore, might have an impact on the validity
of the related certificates or declarations. Under the principles of the new conformity assessment
framework, the only type of organisation that could hold an equipment certificate or issue a
declaration is an approved organisation involved in the design and/or production of ATM/ANS
equipment and, therefore, these activities are to be carried out under the responsibility of the
approved ATM/ANS equipment manufacturer.
Therefore, it could be determined that once the need for a functional change has been established,
the organisation involved in the design and/or production of ATM/ANS equipment is responsible to
specify, design, produce and certify/declare that ATM/ANS equipment. In doing so, the ATM/ANS
equipment manufacturer should establish the maintenance requirements (procedures, periodicity,
etc). Once the ATM/ANS equipment is certified/declared, the user (i.e. the ATM/ANS provider) should
install and integrate it respecting the ATM/ANS equipment manufacturer’s requirements and
undertake the routine maintenance required to ensure that the equipment remains functional and
operational. In this context, Figure 4 illustrates the links between ‘upgrade’ and ‘routine maintenance’.
Figure 4
2.3.3. Transitional provisions

As explained in Section 2.1, Regulation (EC) No 552/2004 of the European Parliament and of the
Council (the interoperability Regulation) was repealed by the Basic Regulation.
In this context, Article 140 ‘Transitional provisions’ of the Basic Regulation prescribes that ‘not later
than 12 September 2023 the implementing rules adopted on the basis of Regulations (EC) No
216/2008 and (EC) No 552/2004 shall be adapted to this Regulation’. Meanwhile, the implementing
rules adopted on the basis of Regulation (EC) No 552/2004 and certain articles of that Regulation and
its related annexes remain applicable until the date of application of the implementing and delegated
acts concerned and, in any case, not later than 12 September 2023. Consequently, the referenced
regulations and associated requirements should be reviewed to enable the harmonised
implementation of the future conceptual, technological, and operational changes introduced with a
simplified regulatory framework.
The risk of a regulatory ‘gap’ could potentially incur after 12 September 2023, should the new
regulatory framework not be in place and applicable on the date on which the current one ceases to
apply. Therefore, as already highlighted, the new framework on the attestation of ATM/ANS
equipment establishes three instruments:
— certification by EASA of safety-critical ATM/ANS equipment;
— declaration by an approved manufacturer for some other critical ATM/ANS equipment; and
— statement of compliance issued by the ATM/ANS provider for all other ATM/ANS equipment,
which constitutes a similar approach to the current EC declarations scheme based on the
interoperability Regulation (Regulation (EU) No 552/2004).
As already detailed in Section 2.3.1.2, it is foreseen that after the entry into force of the new regulatory
ATM/ANS equipment framework, all ATM/ANS equipment already deployed will be deemed to have
been attested in accordance with the new rules. During the transitional period, all equipment will be
subjected to a statement of compliance by the ATM/ANS service providers. Once the
certification/declaration requirements become applicable, ATM/ANS equipment will be certified by
EASA or declared by approved organisations involved in the design and/or production of ATM/ANS
equipment respectively.
In conclusion, this approach would prevent a regulatory ‘gap’ from occurring after 12 September 2023
as well as ensure the necessary continuity of the activities leading to the deployment of new and
upgraded ATM/ANS equipment.
2.3.4. Other associated deliverables

As an outcome of RMT.0161, EASA will issue an opinion during 2023/Q3 resulting from:
— the public consultation of this NPA (Subtask 1) by proposing:
— an implementing act (IA) for the framework as regards the approval of organisations
involved in the design and/or production of ATM/ANS equipment, including the
associated privileges to that approval;
— a delegated act (DA) on the ATM/ANS equipment certification/declaration scheme; and
— an IA amending Regulation (EU) 2017/373 as regards ATM/ANS providers’ responsibilities
in relation to ATM/ANS equipment before integration and deployment;
— the focused consultation of a second NPA (Subtask 2) proposing a revised ATM interoperability
framework pursuant to the Basic Regulation, including the update and transposition of
Regulation (EC) No 29/2009 on data link services for the single European sky13 (the data link
services Regulation), instead of a respective stand-alone proposal. The objective of Subtask 2 is
to review the SES interoperability rules (implementing the repealed Regulation (EC)
13 Commission Regulation (EC) No 29/2009 of 16 January 2009 laying down requirements on data link services
for the single European sky (OJ L 13, 17.1.2009, p. 3) (https://eur-lex.europa.eu/legal-
No 552/2004, Regulation (EC) 1032/200614, Regulation (EC) No 262/200915, Implementing

Regulation (EU) No 1207/201116, etc.) and adapt them to the EASA framework.
This proposal with the draft amending regulations will be issued for consultation with the EASA
Advisory Bodies during 2022/Q4; and
— The public consultation of a third NPA (Subtask 3) proposing a draft decision with the first set
of the detailed (certification/declaration) specifications, acceptable means of compliance (AMC)
and guidance material (GM) to establish the technical and operational conditions necessary to
meet the essential requirements and relevant implementing rules, thus creating a presumption
of conformity in terms of safety, interoperability, and performance. The rationale behind the
publication of the draft detailed (certification/declaration) specifications and the associated
AMC and GM with a separate NPA is to ensure a more focused consultation of the new
regulatory framework.
One of the subjects that will be addressed at AMC level will be the classification of changes to
ATM/ANS equipment, e.g. classification of ‘minor’ and ‘major’ changes.
Safety-related aerodrome equipment which does not fall under ATM/ANS systems and ATM/ANS
constituents (i.e. ATM/ANS equipment) will be addressed in a separate NPA. That NPA will put forward
a draft implementing act on the rules and procedures for the implementation of Article 36
Implementing acts as regards aerodromes and safety-related aerodrome equipment of and Annex VII
Essential requirements for aerodromes to Regulation (EU) 2018/1139 with regard to safety-related
aerodrome equipment.
2.4. What are the expected benefits and drawbacks of the proposed implementing and
delegated acts?
The approval and continuing oversight of organisations involved in the design and/or production of
ATM/ANS equipment, together with the introduction of the different methods of attestation and
demonstration of compliance with the essential requirements applicable to ATM/ANS equipment are
considered to provide the greatest benefits in terms of proportionality.
Furthermore, enhancing the harmonisation of the ATM/ANS equipment requirements will result in
improved efficiency and lower costs for system procurement and maintenance and in improved
operational coordination, thus reducing the fragmentation of the ATM/ANS equipment market and
facilitating industry cooperation at European Union level.
For the detailed impact assessment (IA), please refer to Chapter 4.
14 Commission Regulation (EC) No 1032/2006 of 6 July 2006 laying down requirements for automatic systems
for the exchange of flight data for the purpose of notification, coordination and transfer of flights between air traffic
control units (OJ L 186, 7.7.2006, p. 27) (https://eur-lex.europa.eu/legal-
15 Commission Regulation (EC) No 262/2009 of 30 March 2009 laying down requirements for the coordinated allocation
and use of Mode S interrogator codes for the single European sky (OJ L 84, 31.3.2009, p. 20) (https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009R0262&qid=1658238395551).
16 Commission Implementing Regulation (EU) No 1207/2011 of 22 November 2011 laying down requirements for the
performance and the interoperability of surveillance for the single European sky (OJ L 305, 23.11.2011, p. 35)
(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32011R1207&qid=1658238565140).
3. Proposed implementing and delegated acts
3. Proposed implementing and delegated acts

3.1. Draft regulations (draft EASA opinion)
3.1.1. Draft implementing act laying down technical requirements and administrative procedures
for the approval of organisations involved in the design and/or production of ATM/ANS
systems and ATM/ANS constituents (ATM/ANS equipment) (please refer to Appendix 1)
3.1.2. Draft delegated act laying down common technical requirements and administrative
procedures for the certification and declaration of compliance of the design of ATM/ANS
systems and ATM/ANS constituents (ATM/ANS equipment) (please refer to Appendix 2)
3.1.3. Draft implementing act amending Implementing Regulation (EU) 2017/373 as regards the
conformity assessment of ATM/ANS systems and ATM/ANS constituents (ATM/ANS
equipment) (please refer to Appendix 3)
4. Impact assessment (IA)

4.1. What is the issue
Please refer to Section 2.1.
4.1.1. Safety risk assessment
The need for certification or declaration of certain ATM/ANS equipment is not directly driven by
safety events that have occurred. However, recognising that in the future the provision of ATM/ANS
will rely more heavily on new digital technologies and ATM/ANS systems than today, action at
European Union level is required to ensure the safety and interoperability of such systems.
Moreover, ATM/ANS systems and ATM/ANS constituents (i.e. ATM/ANS equipment) are key and
integral elements of the European ATM network (EATMN) and form a fundamental component to
ensure safe flight operations within the single European sky (SES) airspace.
Failure to establish an EU framework for the attestation of certain ATM/ANS equipment may result
in the implementation of technologies that are not mature to support the required operational
improvements, thus compromising safety, performance and the necessary confidence in solutions
supported by digital technologies and automation.
4.1.2. Who is affected
Mainly manufacturers, i.e. organisations involved in the design and/or production of ATM/ANS
equipment.
ATM/ANS providers will remain responsible for the performance of maintenance and operational
tasks as in the current scenario (i.e. ‘business as usual’), but they will not perform any more activities
in relation to the conformity assessment of the most critical ATM/ANS equipment, focusing only on
the operational integration of the ATM/ANS equipment into the functional ATM/ANS system.
Moreover, according to the currently applicable requirements, especially point ATM/ANS.OR.B.015
Contracted activities of Annex III (Part-ATM/ANS.OR) to Implementing Regulation (EU) 2017/373,
ATM/ANS providers shall ensure that when subcontracting any part of their activities to external
organisations, the purchased system or constituent conforms to the applicable requirements, i.e.
currently, ATM/ANS service providers oversee manufacturers as regards ATM/ANS equipment
subject to purchase and this involves workload for both sides: for manufacturers to demonstrate
compliance of the ATM/ANS equipment, and for ATM/ANS providers to oversee manufacturers.
In addition, similarly, the responsibilities of the ATM/ANS providers’ competent authorities will be
reduced and limited to the oversight of the integration and entry into service of the ATM/ANS
equipment.
EASA will be required to act as the competent authority in relation to the certification and
declaration of certain ATM/ANS equipment and for the approval of organisations involved in its
design and/or production, on top of its current responsibility to act as the competent authority for
pan-European and non-EU ATM/ANS providers.
4.1.3. How could the issue evolve
In the absence of appropriate, specific, and proportionate provisions on the attestation of ATM/ANS
equipment, the currently applicable EC declaration scheme involving differing arrangements
between regulated parties (e.g. national competent authorities, ANSPs, and manufacturers) across
Europe will continue to apply without efficiently facilitating the coordinated introduction of new, EU-
wide agreed and validated concepts of operation and/or technologies due to the following issues:
— the predominance of local (national) technical specifications used in procurement that has led
to the fragmentation of the ATM/ANS equipment market and does not facilitate industry
cooperation at European Union level; therefore, industry needs to considerably adapt its
products to each market, which renders development and implementation of new
technologies unnecessarily difficult and slows down the introduction of new operational
concepts that are required to increase system capacity;
— multiple oversight of ATM/ANS equipment manufacturers by each ATM/ANS provider
purchasing their products (i.e. ATM/ANS equipment) as well as by the national competent
authority of the referenced providers.
In addition, currently, the fact that ATM/ANS providers do not take credit from the
certification/declaration (i.e. attestation) process would lead to the continuation of the
fragmentation of the systems market and the lack of industry cooperation at European Union
Community level; as a result, the industry needs to considerably adapt its products to each national
market due to the lack of harmonised standards for their products leading to delays in the
development of new technologies and slowing down the introduction of new operational concepts
that are required to increase system capacity.
Moreover, the current regulatory framework will continue to support the lack of a level playing field
for the European industry as, currently, ATM/ANS equipment manufacturers do not have access to
oversight credit, contrary to the practice followed in the other aviation domains (e.g. airworthiness).
Furthermore, if no action is taken, the requirements for the issue of EC declarations would cease to
exist after 12 September 2023 and stakeholders would need to continue with the limited instructions
and guidance developed and issued by their national competent authorities to ensure that the
ATM/ANS systems and ATM/ANS constituents are interoperable and operationally suitable in a more
and more complex and integrated ATM/ANS environment.
4.2. What we want to achieve — objectives
Please refer to Section 2.2.
4.3. How we want to achieve it — options

Table 2: Selected options
Option Short title Description

No
0 Baseline Do not implement the Basic Regulation.

(= do nothing) The interoperability framework on the basis of Regulation (EU) No
552/2004 ceases to exist, and stakeholders will need to continue
with the limited instructions and guidance developed and issued by
their national competent authorities to ensure that ATM/ANS
systems and ATM/ANS constituents are interoperable and
operationally suitable in a more and more complex and integrated
ATM/ANS environment, consequently leading to multiple
oversight.
The requirements for ATM/ANS systems and ATM/ANS
constituents would continue to apply in a non-coordinated and
inconsistent manner to the manufacturers of ATM/ANS systems
and ATM/ANS constituents.
1 Introduction of Introduction of the ATM/ANS equipment attestation scheme with

the ATM/ANS the following instruments:
equipment — only certain safety-critical ATM/ANS equipment subject to
attestation scheme certification by EASA;
— other safety-related ATM/ANS equipment subject to
declaration by ATM/ANS equipment manufacturers;
— other ATM/ANS equipment subject to statement of compliance
by ATM/ANS providers.
With this approach, the essential requirements as regards safety,
performance and interoperability would be met.
Note to Option 1:
EASA proposes a single, harmonised and mutually recognised mechanism to attest the compliance
of certain ATM/ANS equipment based on its intended purpose and for the safe and seamless
operation of the EATMN for all phases of flight. The proposals resulting from this option would enable
a holistic, end-to-end, performance-based approach to the provision of ATM/ANS in Europe,
ensuring safety and interoperability.
The detailed (certification/declaration) specifications will be applicable to certain ATM/ANS
equipment for the purpose of complying with the essential requirements set out in Annex VIII and,
if applicable, in Annex VII to the Basic Regulation, and ensuring that the equipment is suitable for
use.
Examples of ATM/ANS equipment for which certification is considered and the associated detailed
(certification) specifications will be developed, consulted, and subsequently issued are:
— flight data processing systems;
— surveillance data processing systems;
— central ATFM systems;

— certain integrations of these systems (e.g.
remote tower system).
Consequently,
— ATM/ANS equipment certificates shall be
issued by EASA after the applicant (an
EASA-approved ATM/ANS equipment
manufacturer) has demonstrated
compliance with the applicable EASA
detailed certification specifications;
— ATM/ANS equipment declarations shall be made by an EASA-approved ATM/ANS equipment
manufacturer that holds an EASA approval with the respective privileges, attesting that the
specific ATM/ANS equipment complies with the EASA detailed declaration specifications.
The ATM/ANS equipment certificates and declarations shall be recognised by all Member States
without any further requirements or evaluation.
As per the requirements of the Basic Regulation, the use of such ATM/ANS equipment by the
ATM/ANS providers shall only be allowed when a certificate or a declaration has been issued.
4.4. Methodology and data
4.4.1. Methodology applied
The methodology applied for this IA is the multi-criteria analysis (MCA), which allows to compare all
the options by scoring them against a set of criteria.
The MCA covers a wide range of techniques that aim to combine a variety of positive and negative
impacts into a single framework to allow an easier comparison of scenarios.
The MCA key steps in this IA include the following:

— establishing the criteria to be used for comparing the options (these criteria must be
measurable, at least in qualitative terms);
— scoring how well each option meets the criteria; the scoring needs to be relative to the
baseline scenario (Option 0); and
— ranking the options by combining their scores.
The criteria used to compare the options were derived from the Basic Regulation, and the guidelines
for the IA were developed by the European Commission. The principal objective of the Basic
Regulation, in accordance with its Article 1(1), is to ‘establish and maintain a high uniform level of
civil aviation safety in the Union’. As additional objectives, the Basic Regulation identifies
environmental, economic, proportionality, and harmonisation aspects, which are reflected below.
For the scoring of the impacts, a scale of –10 to +10 is used to indicate the negative and positive
impacts of each option (i.e. from ‘very high’ to ‘very low’ negative/positive impacts). The
intermediate levels of benefits are termed ‘high’, ‘medium’ and ‘low’ with also a ‘no impact’ score
possible.
Option 1 will be compared with Option 0, which assumes that:
— the current rules on the conformity assessment in the ATM/ANS domain shall apply
until 12 September 2023;
— after 12 September 2023, if no action is taken, the requirements for the issue of EC
declarations would cease to apply, and stakeholders would need to continue with the limited
instructions and guidance developed and issued by their national competent authorities to
ensure that ATM/ANS systems and ATM/ANS constituents are interoperable and operationally
suitable in a more and more complex and integrated ATM/ANS environment.
Remark: Even if the assessment might show negative or positive elements for Option 0 (baseline
scenario), the scores for Option 0 are set equal to 0 in order to allow a straightforward comparability
across the options compared to the baseline scenario.
4.5. What are the impacts
4.5.1. Safety impact
Considering the nature and the risks associated with the operation of the Single European Airspace
System (SEAS), all ATM/ANS equipment that supports the ATM/ANS functions and services listed in
Annex VIII to the Basic Regulation and the organisations that design and produce such equipment
should be subjected to a proportionate level of attestation. The attestation will be considered
accomplished once the certificate that demonstrates compliance is issued or the declaration is made,
based on the equipment’s safety criticality and benefits for the relevant stakeholders, while the
organisations involved in the design and/or production of certain ATM/ANS equipment are to be
subjected to certification with the respective privileges.
In addition, the use and sharing of aeronautical data within the EATMN is paramount in ensuring safe
and efficient operations. It is, therefore, fundamental that safety-relevant ATM/ANS equipment, and
other ATM/ANS equipment on which the interoperability and safety of operations depend, conform
to a common set of detailed specifications established by EASA.
With Option 0, the current situation will remain unchanged until 12 September 2023 while,
thereafter, if no action is taken, stakeholders would need to deploy new technologies in a more
complex and integrated ATM/ANS environment without ensuring in a standardised manner that the
ATM/ANS equipment is safe and fit for the intended use. This might have negative consequences on
safety.
With Option 1, ATM/ANS providers will establish robust processes for the deployment of new
technologies that are conducive to safety. However, as a result of the new ATM/ANS equipment
attestation scheme, an increase in the overall safety is foreseen to be ‘low’ positive (indicated as +4
in the Table 3).
The conformity assessment shall allow to demonstrate that ATM/ANS equipment meets the
applicable requirements, thus ensuring that operational expectations are met with emphasis on safe
and interoperable operations. It shall contribute to minimise technical failures or malfunctions which
may potentially have safety impacts (e.g. due to aircraft deviating from the safe flight path).
Therefore, a formal process to check equipment suitability for use is considered essential.
Hence, Option 1 meets the following objectives as detailed in Section 2.2:
— Minimise any undesirable implementation issues that may compromise the operational
functionalities, and promote technical interoperability through the use, where available, of
detailed specifications.
— The appropriate implementation and operation of certain technologies (enablers) may be
dedicated to obtaining particular safety gains.
For certain ATM/ANS equipment, the use of common requirements at EU level is beneficial
where technical harmonisation can contribute towards meeting the safety goals, and
necessary where there are interfaces with other systems. The proposed framework will enable
enhanced harmonisation through the use of the EASA detailed specifications, and the concrete
benefits will be evaluated whenever these detailed specifications are made available in
support of a particular application.
Even if the lack of harmonised technical specifications has so far rarely led to safety issues, the
desire to implement a distributed architecture implies greater interdependence between
systems and organisations and, therefore, increased level of interoperability. Consequently,
harmonised technical standards and formal attestation are significant enablers for the safe
deployment of distributed architectures.
Moreover, Option 1 considers the integration of conformity assessment activities in the
procedures which ATM/ANS providers have established already in order to manage and assess
the safe deployment of ATM/ANS equipment.
In addition, Option 1 considers an increased and more streamlined role of the national
competent authorities in the verification of ATM/ANS equipment before its integration into
the ATM/ANS functional system that may be relevant for safety considerations. This should
contribute to a more robust approach as regards oversight of ATM/ANS equipment.
— Facilitate the safe and interoperable development and implementation of new technologies
by stakeholders, where such technologies are designed to have a positive impact in line with
the European ATM Master Plan.
Option 1 supports the safe implementation of new technologies in two ways:
— It allows the accelerated deployment of new functionalities as enabled by the EASA detailed
specifications (and the necessary standardisation material). The mandatory application of the
EASA detailed specifications (as opposed to the voluntary use of Community specifications17)
is also expected to reduce the potential for unsafe deployment.
— It ensures that deployment is subject to a streamlined assurance process, which is led by the
ATM/ANS provider and proportionate to the potential safety impact of the changes to the
ATM/ANS functional system.
17 Community specifications (europa.eu)
Table 3: Safety impacts
Option Short title Description Score
0 Baseline (= do Do not implement the Basic Regulation. 0

nothing) The ultimate responsibility as regards safety will
remain within the ATM/ANS providers’ remit.
1 Introduction of the Improved ability to introduce safety enablers. +4

ATM/ANS equipment Improved ability to ensure the safe and interoperable
attestation scheme deployment of new technologies.
Improved oversight of the technical requirements
and the related compliance demonstration
processes.
4.5.2. Environmental impact
n/a
4.5.3. Social impact

n/a
4.5.4. Economic impact
With Option 0, the current situation will remain unchanged until 12 September 2023 while,
thereafter, if no action is taken, stakeholders (ATM/ANS providers and national competent
authorities) would need to allocate more resources for the assessment of the integration of new
technologies before deploying them in a more complex and integrated ATM/ANS environment,
which could even lead to further fragmentation of the ATM/ANS equipment market.
With Option 1, one of the main impacts of the proposed regulatory framework, and the main area
where the regulatory options can be differentiated, is in economic terms and in particular the effect
on the cost of the associated equipment.
As regards the economic impact, the following objectives are considered:
— promote cost-efficiency by, inter alia, avoiding duplication and promoting effectiveness in the
certification and oversight processes as well as the efficient use of related resources at
European Union and national level by avoiding multiple oversight by the ATM/ANS providers
that purchase ATM/ANS equipment and their competent authorities, and optimise the use of
resources during the demonstration of compliance by reducing the administrative burden;
— promote internal and external market opportunities by ensuring fair competition and by
facilitating the free movement of ATM/ANS equipment through the mutual recognition by the
EU Member States of certificates or declarations, where applicable, without further
evaluation.
PROMOTE COST-EFFICIENCY
Impact on ATM/ANS equipment manufacturers: Design and/or production organisations of
ATM/ANS equipment are required to design and/or produce equipment in line with the respective
applicable essential requirements. The proposed regulatory framework considers their nature and
the associated risks and, therefore, all systems that support the ATM/ANS functions and services
listed in Annex VIII Essential requirements for ATM/ANS and air traffic controllers to the Basic
Regulation should not be subject to the same level of attestation, i.e. based on the risk of the
particular activity and the benefits for the relevant stakeholders, certain ATM/ANS equipment should
be subject to certification, while other ATM/ANS equipment should be subject to declaration, and
other to no attestation at all.
Where formal attestation is required, the proposal does require the approval of the DPO by
demonstrating compliance that should be commensurate with the complexity of its activities.
Therefore, this option promotes the reuse of the ATM/ANS equipment manufacturer’s processes
whilst ensuring their adequacy.
ATM/ANS equipment manufacturers will face additional cost to adapt their working methods and
procedures, as well as the organisational approval and ATM/ANS equipment certification cost.
However, that cost would be compensated over time by the decrease in the workload for the
applicant with the multiple oversight of the ATM/ANS providers that purchase the equipment and
their competent authorities.
The option for organisations involved in the design and/or production of ATM/ANS equipment to
make declarations on their own based on their associated privileges will simplify and streamline their
coordination with the ATM/ANS providers.
Compared to Option 0, for ATM/ANS equipment subject to a Statement of Compliance (SoC), the
coordination between ATM/ANS providers and ATM/ANS equipment manufacturers will not be
affected. Indeed, even if no Declaration for Suitability for Use (DSU) or Declaration of Compliance
(DoC) is formally required from ATM/ANS equipment manufacturers, ATM/ANS providers will need
inputs and support from ATM/ANS equipment manufacturers to develop their SoCs.
The benefit of the proposed concept is the avoidance of oversight by those ATM/ANS providers that
purchase equipment from ATM/ANS equipment manufacturers on the basis of evidence provided
with the ATM/ANS equipment certificates and organisational approvals issued by EASA. In addition,
when assessing the number of audits (and the related workload) of ATM/ANS equipment
manufacturers by ATM/ANS providers, the total decrease in the workload and the associated cost
could be quantified in the average of 10–15 %18 of the total cost for the acquisition of ATM/ANS
equipment.
Impact on ATM/ANS providers: ATM/ANS providers involved in changes to ATM/ANS equipment,
and their oversight authorities, are currently required to follow two assessment processes before
putting equipment into service, which results from:
— the conformity assessment based on the interoperability Regulation (Regulation (EC)
No 552/2004); and
— the management of change as per Implementing Regulation (EU) 2017/373.
Whilst these two assessment processes are different in terms of objectives, both require
coordination as they impact on each other. The proposal simplifies the overall process and maximises
18 Based on feedback collected via interviews and surveys to some ATM/ANS providers and ATM/ANS equipment
manufacturers.
the synergies with the rest of the activities concerning the verification of ATM/ANS equipment before
it is put into operation/service.
ATM/ANS providers will benefit from the presumption of conformity afforded by the attestation, i.e.
by a certificate or declaration, which reduces the effort required to gain technical approval (e.g.
testing and equipment verification activities). In particular, ATM/ANS providers will be required to
demonstrate compliance by benefiting from the ATM/ANS equipment attestation before integrating
it into the ATM/ANS functional system instead of fully verifying the system and developing a
technical file as required by the existing framework. The evidence for successful integration is
provided by the documentation associated with the assurance of changes to ATM/ANS functional
systems applicable to ATM/ANS providers. It is also anticipated that the approval and oversight of
the organisations involved in the design and/or production of ATM/ANS equipment as well as the
certificates and declarations of products will help ATM/ANS providers build greater trust with their
suppliers and, hence, reduce the cost of testing and verification during the integration process.
In conclusion, compared to the existing framework, the new proposal is streamlined. ATM/ANS
providers will be required to adapt their procedures, but this adaptation will translate into process
simplification and enhanced coordination in the medium term. Overall, the new proposal will
promote an overall harmonisation of the process and reduction in administrative burden that should
in turn lead to lower cost in the medium term.
Impact on competent authorities, including EASA: The regulatory proposal concerns the
establishment of common rules for ATM/ANS equipment within the EU, thus avoiding duplication
and promoting effectiveness in the regulatory, certification and oversight processes as well as the
efficient use of related resources at Union and national level. The oversight by the national
competent authorities will focus on the integration of the ATM/ANS equipment; therefore, they will
experience a cost reduction as all activities linked to the conformity assessment of the most critical
ATM/ANS equipment will not be necessary any more at national level. On EASA’s side, the
implementation of Option 1 will require to plan well in advance the necessary resources for the initial
certification and continuing oversight. However, the certification will fall under the Fees & Charges
scheme to recover EASA’s costs from the approved manufacturers as well as from the certification
of the applicable ATM/ANS equipment. Consequently, the impact on EASA will be neutral.
PROMOTE INTERNAL AND EXTERNAL MARKET OPPORTUNITIES

Two key aspects are considered, namely the design and production cost and its potential impact on
the price of the equipment, and the competitiveness of the respective market.
In terms of equipment design and production cost, there are several new requirements that
ATM/ANS equipment manufacturers will have to meet such as the development and management
of the related certification programme. Furthermore, for certain ATM/ANS equipment, the
certification cost, where applicable, would also impact on the aggregated equipment design and
production cost. Therefore, a higher production cost could imply pressure in the short term to
increase the price of ATM/ANS equipment.
However, for cases where EASA detailed (certification/declaration) specifications have been
established, it will ensure a level playing field as regards the product market while the level of the
tailoring required will be driven by the local specificities, which in the medium term will have a
positive impact by reducing the aggregated design and production cost.
For those cases where EASA detailed (certification/declaration) specifications have not been
established, the related procurement specifications issued by the client will need to specify the
related requirements to ensure that the delivered equipment meets the essential requirements.
In this case, the lack of common specifications could lead to tailored products with higher design and
production cost, similarly to today’s scenario. As the proposed rules provide for the
certification/declaration of certain ATM/ANS equipment by its manufacturers, it is anticipated that

this will greatly increase the commonality of equipment specifications and support the recognition
of equipment by both EU and non-EU markets.
In the case an approved organisation has been granted the privilege to issue declarations, the cost is
expected to be lower especially when ATM/ANS equipment manufacturers that provide a range of
products are subject to the EASA declaration specifications since:
— the upfront cost of achieving organisation approval can be split over a greater range of
products, especially if they are intended for long serial production; and
— the cost of liaising with EASA acting as the competent authority will be lower due to the
promotion of a single authority for approval/certification and oversight.
Stakeholders Economic impact
ATM/ANS equipment Formal ATM/ANS equipment attestation required, as well as additional cost
manufacturers related to the approval of organisations involved in the manufacturing of the
equipment concerned.
Multiple positive economic impacts of equipment harmonisation in the
medium term that could lead to cost reduction through efficient product
policy implementation, reducing aggregated manufacturing cost and
increasing the competitiveness of the EU industry.
EASA organisational approval and ATM/ANS equipment certification/
declaration would bring a positive economic impact as it will be mutually
recognised both in EU and non-EU markets.
ATM/ANS service providers Benefits from the presumption of conformity afforded by the attestation,
certification or declaration by reducing the amount of effort required to
demonstrate ATM/ANS equipment compliance before introducing changes
to its functional system.
Process simplification and coordination in the medium term.
National competent Reduced oversight scope with more focus on the service level approval, i.e.
authorities (NCAs) the approval of the change(s) to the functional system of the ATM/ANS
providers.
EASA Initial additional effort for EASA in relation to organisation approvals and
ATM/ANS equipment certification activities that would be compensated by
the Fees & Charges scheme implemented by EASA, i.e. the cost will be
neutral.
Illustrative examples of the potential economic benefits could be observed in the PRB Monitoring
Report 2019, especially Annex IV – CAPEX report. The ATM/ANS equipment that could be subject to
certification and cost saving could be related to the following:
— ATM systems: iCAS, iTEC, 4-Flight, Co-Flight, COOPANS, TopSky;
— Tower support systems: ASMGCS, AMAN, DMAN, ACDM, remote towers;
— Information services: AIM/AIS, MET.
Option 1 is considered to have a medium positive economic impact over time compared to the
current scenario.
Table 4: Economic impact
0 Baseline (= do No change to the current practice 0

nothing)
1 Introduction of the While the additional cost for ATM/ANS equipment +6

ATM/ANS equipment manufacturers and EASA would increase in the short
attestation scheme term, in the medium to long term the overall design
and/or production cost would decrease, and further
economic benefits achieved from market
development would be expected.
Request to stakeholders
Stakeholders are invited to provide:

— quantified justification elements on the possible impacts (e.g. economic and safety) of the
options proposed, or alternatively propose a justified solution to the issue;
— any other information they may find necessary to bring to the attention of EASA; as a result,
the relevant parts of the IA might be modified on a case-by-case basis.
4.5.5. Proportionality issues

With respect to proportionality, it is considered whether the proposals would have a
disproportionate impact on stakeholders such as, e.g., ATM/ANS equipment manufacturers and
ATM/ANS providers. As today the process for demonstrating ATM/ANS equipment compliance is not
subject to formal attestation, and compared to the current system, it is considered streamlined to
some extent.
Option 1:
Impact on ATM/ANS equipment manufacturers. As discussed under the economic impact, there is
an additional cost for ATM/ANS equipment manufacturers in establishing and following a
certification programme under the supervision of EASA. It is also noted that a new applicant would
benefit from the guidance the interaction with EASA will offer, as it would ensure that the process
put in place to develop its products is adequate for certification. It offers the ability for ATM/ANS
equipment manufacturers to simplify and at the same time upgrade their processes for complex
equipment to attract more customers.
Impact on ATM/ANS providers. The development of harmonised equipment subject to formal
attestation is likely to have a more positive impact on non-complex ATM/ANS providers as they will
benefit more from the availability of certified/declared products. This is particularly true for AFIS
providers as the possibility to procure ATM/ANS equipment that is already certified or declared by
an approved organisation involved in its design and/or production would ease the demonstration of
compliance with the essential requirements for both AFIS providers and their competent authorities,
which in turn would provide for cost-efficiency and a reduction in human resources needs.
Compared to the current scenario, the implementation of Option 1 is considered to have a positive
impact (+4) as regards proportionality.
Conclusions regarding proportionality
Table 5: Proportionality impact

0 Baseline (= do No change to the status. 0

nothing)
1 Introduction of the The availability of certified/declared ATM/ANS +4

ATM/ANS equipment equipment would benefit small and non-complex
attestation scheme ATM/ANS providers, and possibly aerodrome
operators, due to the reduced implementation cost.
Equipment certification/organisation approval would
support new entrants in ensuring their processes are
fit for purpose.
4.6. Conclusion
The summary of the impacts for each option is provided in Table 6.
Table 6: Comparison of the options
Option Short title Safety Economic Proportionality Overall
0 Baseline (= do nothing) 0 0 0 0
1 Introduction of the
ATM/ANS equipment +4 +6 +4 +14
attestation scheme
The approval and continuing oversight of ATM/ANS equipment manufacturers (Option 1), together
with the introduction of the different methods of attestation and demonstration of compliance with
the essential requirements applicable to ATM/ANS equipment is the preferred option since it
provides the greatest benefits in terms of proportionality.
Furthermore, enhancing the level of common, harmonised system requirements would result in
greater efficiency and lower cost for system procurement and maintenance and in improved
operational coordination thus reducing the fragmentation of the ATM/ANS equipment market and
facilitating industry cooperation at European level.
4.7. Monitoring and evaluation

As this NPA introduces a certification and declaration scheme for certain ATM/ANS equipment that
will apply to new and updated ATM/ANS equipment designs, the monitoring of the effects produced
by the new measures will consist of the following:
(a) feedback from future ATM/ANS equipment certification projects; and
(b) in the long term, the trend of the issues encountered with the ATM/ANS equipment during
the investigation of accidents and incidents, as well as other feedback from ATM/ANS
equipment manufacturers, ATM/ANS service providers, and oversight authorities.
Item (a) depends on the applications received after the adoption and applicability of the proposed
regulatory framework as well as the issue and publication of the EASA detailed
certification/declaration specifications.
Further to monitoring, an evaluation might be performed in the long term but in any case not earlier
than 5 years after the date of applicability of the detailed certification/declaration specifications
issued by EASA, and it would require the availability of experience gained from several ATM/ANS
equipment certification projects.
Item (b) would be available once new ATM/ANS equipment designs have entered into service and
sufficient experience has been gained with their operation, which would require several years.
5. Proposed actions to support implementation
5. Proposed actions to support implementation

EASA will consider the most appropriate method to support the implementation of this proposal by
applying one of the following actions, as appropriate:
— Focused communication for Advisory Body meeting(s) (MAB/SAB/TeB/TEC/COM)
(Advisory Body members)
— Detailed explanation with clarifications on the EASA website
(Primarily targeted audience: industry, competent authorities)
— Dedicated thematic workshop/session
(Primarily targeted audience: industry, competent authorities)
6. References
6. References
6.1. Related EU regulations
— Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on
common rules in the field of civil aviation and establishing a European Union Aviation Safety
Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010,
(EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and
of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the
European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212,
22.8.2018, p. 1)
— Commission Implementing Regulation (EU) 2017/373 of 1 March 2017 laying down common
requirements for providers of air traffic management/air navigation services and other air
traffic management network functions and their oversight, repealing Regulation (EC) No
482/2008, Implementing Regulations (EU) No 1034/2011, (EU) No 1035/2011 and (EU)
2016/1377 and amending Regulation (EU) No 677/2011 (OJ L 62, 8.3.2017, p. 1)
6.2. Related EASA decisions

n/a
6.3. Other references

— Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004
on the interoperability of the European Air Traffic Management network (the interoperability
Regulation) (OJ L 96, 31.3.2004, p. 26)
7. Quality of the NPA
7. Quality of the NPA

To continuously improve the quality of its documents, EASA welcomes your feedback on the quality
of this NPA with regard to the following aspects:
7.1. The regulatory proposal is of technically good/high quality

[Please choose one of the options below and place it as a comment in CRT; if you disagree or strongly disagree,
please provide a brief justification.]
Fully agree / Agree / Neutral / Disagree / Strongly disagree
7.2. The text is clear, readable and understandable

7.3. The regulatory proposal is well justified

7.4. The regulatory proposal is fit for purpose (capable of achieving the objectives set)
7.5. The impact assessment (IA), as well as its qualitative and quantitative data, is of high
quality
7.6. The regulatory proposal applies the ‘better regulation’ principles[1]

7.7. Any other comments on the quality of this NPA (please specify)
Note: Your comments on this Section will be considered for internal quality assurance and
management purposes only and will not be published in the related CRD.
[1] For information and guidance, see:

− https://ec.europa.eu/info/law/law-making-process/planning-and-proposing-law/better-regulation-why-and-
how_en
how/better-regulation-guidelines-and-toolbox_en
how/better-regulation-guidelines-and-toolbox/better-regulation-toolbox_en
8. Appendices
8. Appendices
8.1. Appendix 1: DRAFT COMMISSION IMPLEMENTING REGULATION (EU) …/... laying
down technical requirements and administrative procedures for the approval of
organisations involved in the design and/or production of ATM/ANS systems and
ATM/ANS constituents
DRAFT COMMISSION IMPLEMENTING REGULATION (EU) …/...
of XXX
laying down technical requirements and administrative procedures for the approval of
organisations involved in the design and/or production of ATM/ANS systems and
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,
Having regard to […]19, and in particular Article […] thereof,
Whereas:
(1) [Initial capital…].
(3) The measures provided for in this Regulation are in accordance with the opinion of the
[…] committee, [for acts adopted after consultation of a committee under the
examination procedure],
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation lays down, pursuant to Articles 42(1)(b) and 43(1) of Regulation (EU)
2018/1139, technical requirements and administrative procedures for the approval of
organisations involved in the design and/or production of ATM/ANS systems and ATM/ANS
constituents (ATM/ANS equipment).
Article 2
Definitions
For the purpose of this Regulation, ‘ATM/ANS equipment’ means ATM/ANS constituents as
defined by Article 3(6) of Regulation (EU) 2018/1139, and ATM/ANS systems as defined by
Article 3(7) of that Regulation, excluding airborne constituents.
19
OJ L […], […], p. […].
8. Appendices
Article 3
Competent authority requirements
1. For the purposes of this Regulation, the competent authority responsible for the issue of
approvals to organisations involved in the design, and/or production of ATM/ANS
equipment and for the oversight and enforcement in respect of those organisations, shall
be the Agency pursuant to Article 80(1)(c) of Regulation (EU) 2018/1139.
2. The Agency shall fulfil the detailed requirements laid down in Annex I (Part-
ATM/ANS.EQMT.AR) to Delegated Regulation (EU) …/… [delegated act on the
attestation of ATM/ANS equipment] when conducting certification, investigations,
inspections, audits and other monitoring activities necessary to ensure the effective
oversight of organisations involved in the design, and/or production of ATM/ANS
equipment subject to this Regulation.
Article 4
Organisations involved in the design, and/or production of ATM/ANS equipment
An organisation involved in the design, production or maintenance of ATM/ANS equipment
shall demonstrate its capability in this regard in accordance with the Annex (Part-DPO.OR) to
this Regulation.
Question 8.1 #1
At present, EASA has not established any bilateral working arrangements to address technical
ATM/ANS equipment issues. However, it is proposed to establish such bilateral working
arrangements and offer the possibility for derogation from the provisions of the above-
mentioned Article 4.
Stakeholders are invited to comment on the proposal and, where they believe it is not sufficient,
make additional proposals, including justifications.
E.g. ‘By way of derogation from point 1, an organisation whose principal place of business is
in a non-Member State, may demonstrate its capability by holding a certificate issued by that
State for the organisation involved in the design, production or maintenance of ATM/ANS
equipment, for which it applies, provided that the Agency has determined that the system of
that State includes the same independent level of checking of compliance as provided for by
this Regulation, either through an equivalent system of approvals of organisations or through
the direct involvement of the competent authority(ies) of that State.’
Article 5
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
8. Appendices
Done at Brussels,
For the Commission

The President
[…]
8. Appendices
ANNEX
REQUIREMENTS FOR ORGANISATIONS INVOLVED IN THE DESIGN AND/OR
PRODUCTION OF ATM/ANS EQUIPMENT
(Part-DPO.OR)
SUBPART A — GENERAL REQUIREMENTS (DPO.OR.A)
DPO.OR.A.001 Scope
This Annex establishes the common requirements as regards the rights and obligations of an
applicant for, and a holder of, an organisation approval for the design and/or production of
ATM/ANS equipment.
DPO.OR.A.005 Eligibility
Any natural or legal person who has demonstrated, or is in the process of demonstrating, their
capability to design and/or produce ATM/ANS equipment in accordance with point
DPO.OR.A.010, may apply for a design and/or production organisation approval under the
conditions laid down in this Annex.
DPO.OR.A.010 Application for a design and/or production organisation approval and

demonstration of compliance
(a) An application for an approval under this Regulation shall be made in a form and manner
established by the Agency.
(b) In order to obtain an approval, an organisation involved in the design and/or production
of ATM/ANS equipment shall comply with the requirements set out in this Annex where
those requirements are applicable to the activities the organisation involved in the design
and/or production of ATM/ANS equipment performs or intends to perform.
DPO.OR.A.015 Organisation exposition

(a) An organisation involved in the design and/or production of ATM/ANS equipment shall
establish and maintain an exposition, which provides the following information:
(1) statement signed by the accountable manager who confirms that the organisation
exposition and any associated manuals, which describe how the organisation
implements the provisions of this Regulation, are complied with at all times;
(2) the title(s) and name(s) of the key manager(s);
(3) the duties and responsibilities of the manager(s), including matters for which they
may deal directly with the Agency on behalf of the organisation;
(4) an organisational chart that shows the associated chains of responsibility of the
managers;
(5) a general description of the organisation’s human resources;
(6) a general description of the facilities located at each location specified in the
organisation’s approval;
(7) a general description of the organisation’s scope of work relevant to the terms of
approval;
8. Appendices
(8) the procedure(s) for the verification and demonstration that the design of
ATM/ANS equipment, or changes to it, complies with the applicable detailed
specifications and requirements as established by Delegated Regulation (EU) …/…
[delegated act on the attestation of ATM/ANS equipment] and has no unsafe
features, as applicable;
(9) the procedure for the preparation and maintenance of the technical data and records,
for each model of each piece of ATM/ANS equipment for which a certificate or
declaration of design has been issued in accordance with Implementing Regulation
(EU) …/… [implementing act on the approval of DPOs], as applicable;
(10) the procedure for the notification of organisational changes to the Agency;
(11) the amendment procedure for the organisation’s exposition;
(12) a description, direct or by cross reference, of the organisation’s management
system and procedures;
(13) a list of the contracted organisations referred to in point DPO.OR.B.015 of this
Annex.
(b) The exposition shall be amended as necessary to remain an up-to-date description of the
organisation, and a copy of it, including its amendments, shall be supplied to the Agency.
(c) An application for a change approval referred to in point DPO.OR.B.005 of this Annex
shall be based on the submission of the proposed changes to the exposition.
DPO.OR.A.015 Means of compliance

(a) Alternative means of compliance to the acceptable means of compliance (AMC) adopted
by the Agency may be used by an organisation involved in the design and/or production
of ATM/ANS equipment to establish and demonstrate compliance with Regulation (EU)
2018/1139 and its delegated and implementing acts.
(b) When an organisation wishes to use an alternative means of compliance, it shall, prior to
using it, provide the Agency with a full description of that alternative means of
compliance. The description shall include any revisions to manuals or procedures that
may be relevant, as well as an assessment that demonstrates compliance with Regulation
(EU) 2018/1139 and its delegated and implementing acts.
An organisation involved in the design and/or production of ATM/ANS equipment may
use any alternative means of compliance subject to prior approval by the Agency and
upon receipt of the notification as provided for in point (d) to point
ATM/ANS.EQMT.AR.A.020 of Annex I (Part-ATM/ANS.EQMT.AR) to Delegated
Regulation (EU) …/… [delegated act on the attestation of ATM/ANS equipment].
PDO.OR.A.020 Continued validity of an organisation approval

(a) An organisation’s approval shall remain valid for an unlimited period of time provided
that:
(1) the organisation remains compliant with the applicable requirements of this
Regulation;
(2) the approval has not been surrendered by the organisation or suspended or revoked
by the Agency.
8. Appendices
(b) Upon revocation or surrender of the approval, if issued in a paper format, it shall be
returned to the Agency without delay.
DPO.OR.A.025 Facilitation and cooperation

An organisation involved in the design or production of ATM/ANS equipment shall facilitate
the inspections and audits performed by the Agency or by a qualified entity that acts on its
behalf, and it shall cooperate as necessary for the efficient and effective exercise of the powers
of the Agency.
DPO.OR.A.030 Findings and corrective actions

Following the receipt of the notification of findings from the Agency, the organisation involved
in the design and/or production of ATM/ANS equipment shall:
(a) identify the root cause of the non-compliance;
(b) define a corrective action plan; and
(c) demonstrate the implementation of the corrective action to the satisfaction of the Agency
within the time period proposed and approved by the Agency, as defined in point (e)(2)
of point ATM/ANS.EQMT.AR.C.020 of Annex I (Part-ATM/ANS.EQMT.AR) to
Delegated Regulation (EU) …/… [delegated act on the attestation of ATM/ANS
equipment].
DPO.OR.A.035 Immediate reaction to a safety and interoperability problem

An organisation involved in the design and/or production of ATM/ANS equipment shall
implement any safety measures, including ATM/ANS equipment directives, mandated by the
Agency in accordance with point ATM/ANS.EQMT.AR.025 of Delegated Regulation (EU)
…/… [delegated act on the attestation of ATM/ANS equipment].
DPO.OR.A.040 Failures, malfunctions, and defects

(a) The holder of an approval issued in accordance with this Regulation shall:
(1) establish and maintain a system for collecting, investigating and analysing reports
of and information on failures, malfunctions, defects or other occurrences which
have caused or might cause adverse effects on the continuing compliance of the
ATM/ANS equipment with the applicable requirements; and
(2) inform all known users of the ATM/ANS equipment concerned and, on request,
any person mandated under other associated regulations about the system
established in accordance with point (a)(1) and on how to provide such reports of
and information on failures, malfunctions, defects or other occurrences.
(b) For organisations that have their principal place of business in a Member State, the
system established in accordance with point (a)(1) shall include provisions for mandatory
and voluntary occurrence reporting and follow-up that meet the requirements of
Regulation (EU) No 376/2014 and of Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on their basis.
(c) The approval holder shall report to the Agency any failure, malfunction, defect or other
occurrence of which it is aware, and which has resulted or may result in an unsafe or
underperformance condition.
8. Appendices
(d) For approval holders that do not have their principal place of business in a Member State,
reports shall be made in a form and manner established by the Agency, as soon as
practicable and in any case submitted not later than 72 hours after the person or
organisation has become aware of the particular occurrence, unless exceptional
circumstances prevent this.
(e) The approval holder shall investigate an occurrence that has been reported under point
(c), including the deficiencies that have led to that occurrence, and report to the Agency
the results of its investigation and any action it intends to take or proposes to take to
correct these deficiencies.
DPO.OR.A.045 Approval transferability
An organisation approval is not transferable, except only as a result of a change in the
ownership of the approval.
SUBPART B — MANAGEMENT (DPO.OR.B)
DPO.OR.B.001 Management system

(a) An organisation involved in the design or production of ATM/ANS equipment shall
implement and maintain a management system that includes the following:
(1) clearly defined lines of responsibility and accountability throughout its
organisation, including a direct accountability of the accountable manager;
(2) a description of the overall philosophy and principles of the organisation,
collectively constituting a policy, signed by the accountable manager;
(3) the means to verify the performance of the organisation in the light of the
performance indicators and performance targets of the management system;
(4) a process to identify changes within the organisation and the context in which it
operates, which may affect established processes, procedures and products and,
where necessary, change the management system to accommodate those changes;
(5) a process to identify the scope of changes to certain ATM/ANS equipment and the
associated risk;
(6) a process to review the management system, identify the causes of substandard
performance of the management system, determine the implications of such
substandard performance, and eliminate or mitigate such causes;
(7) a process to ensure that the personnel of the organisation are trained and competent
to perform their duties in a safe, efficient, continuous and sustainable manner;
in this context, the organisation shall establish policies for the recruitment and
training of its personnel;
(8) a formal means for communication which ensures that all personnel of the
organisation are fully aware of the management system that allows critical
information to be communicated and that makes it possible to explain why
particular actions are taken and why procedures are introduced or changed;
(9) as regards design activities:
(i) control procedure(s) for the design of ATM/ANS equipment, and for changes
to its design;
8. Appendices
(ii) assurance that the design of ATM/ANS equipment, or the changes to its
design, comply with the applicable specifications, including independent
checking function of the demonstration of compliance on the basis of which
the organisation submits compliance statements and associated
documentation to the Agency; and
(iii) procedure(s) for the verification of the acceptability of the elements of the
ATM/ANS equipment designed, or the tasks performed, by the contracted
organisations referred to in point DPO.OR.B.015;
(iv) staff involved in the design of ATM/ANS equipment are of sufficient
numbers and have considerable experience, and have been authorised to
discharge their allocated responsibilities;
(v) assurance that there is close and efficient coordination between departments
and within departments;
(10) as regards production activities, control procedures for:
(i) the issue and approval of documents, or changes to them;
(ii) assessment audits and the control of contracted organisations referred to in
point DPO.OR.B.015;
(iii) verifying that incoming products, parts, materials and equipment, including
the supply of new items or items used by product buyers, are as specified in
the applicable design data;
(iv) verifying that ATM/ANS equipment conforms to the applicable design data;
(v) identification and traceability;
(vi) organisation processes;
(vii) inspection and testing;
(viii) calibration of tools, jigs, and test equipment;
(ix) the control of non-conforming items;
(x) the coordination with the applicant for, or holder of, the design approval;
(xi) the completion and retention of records of work carried out;
(xii) the issue of release documents;
(xiii) the handling, storage and packing of ATM/ANS equipment.
(b) An organisation involved in the design and/or production of ATM/ANS equipment shall
document all key management system processes, including a process for making
personnel aware of their responsibilities, and the procedure for amending those
processes.
(c) An organisation involved in the design and/or production of ATM/ANS equipment shall
establish a function to monitor its compliance with the applicable requirements and the
adequacy of the established procedures. Compliance monitoring shall include a feedback
system of findings to the accountable manager to ensure the effective implementation of
corrective actions, as necessary.
8. Appendices
(d) The management system shall be proportionate to the size of the organisation involved
in the design and/or production of ATM/ANS equipment and the complexity of its
activities, taking into account the hazards and associated risks inherent in those activities.
DPO.OR.B.005 Change management
(a) Following the issue of an organisation’s certificate, any change to the management
system that is significant for the demonstration of compliance shall be approved by the
Agency before it is implemented.
(b) Each change made to the ATM/ANS equipment shall be notified to the Agency by
following the approved procedure, defining the classification of the changes to the
ATM/ANS equipment and describing how such changes will be notified and managed.
DPO.OR.B.010 Facility requirements

An organisation involved in the design and/or production of ATM/ANS equipment shall ensure
that its facilities and equipment are adequate and suitable to perform and manage all its tasks
and activities in accordance with the applicable requirements.
DPO.OR.B.015 Contracted activities

(a) Contracted activities include all those activities that are within the scope of the
organisation’s activities, in accordance with the terms of the certificate, which are
performed by other organisations either themselves certified to carry out such activities
or, if not certified, working under the organisation’s supervision. An organisation
involved in the design and/or production of ATM/ANS equipment shall ensure that when
it contracts any part of its activities to or when it purchases any part of its activities from
external organisations, the contracted or purchased activity, as applicable, conforms with
the applicable requirements.
(b) When an organisation involved in the design and/or production of ATM/ANS equipment
contracts any part of its activities to an organisation that is not itself certified in
accordance with this Regulation to carry out such activities, it shall ensure that the
contracted organisation works under its supervision. An organisation involved in the
design and/or production of ATM/ANS equipment shall ensure that the Agency is given
access to the contracted organisation to determine its continued compliance with the
applicable requirements of this Regulation.
DPO.OR.B.020 Personnel requirements

appoint an accountable manager who has the authority to ensure that all activities may
be financed and carried out in accordance with the applicable requirements of this
Regulation. The accountable manager shall be responsible for establishing and
maintaining an effective management system.
(b) The authority, duties, and responsibilities of the nominated postholders, in particular of
management personnel in charge of safety-, quality-, security-, finance- and human-
resources-related functions, as applicable, shall also be defined.
8. Appendices
DPO.OR.B.025 Record-keeping
establish a record-keeping system that allows for the adequate storage of records and the
reliable traceability of all its activities, covering in particular all the elements indicated
in point DPO.OR.B.001 of this Annex.
(b) The format and the retention period of the records referred to in point (a) shall be
specified in the organisation’s management system procedures.
(c) Records shall be stored in a manner that ensures their protection against damage,
alteration, and theft.
(d) An organisation involved in the design and/or production of ATM/ANS equipment shall
maintain a register of the ATM/ANS users that deploy its ATM/ANS equipment.
SUBPART C — TECHNICAL REQUIREMENTS (DPO.OR.C)
DPO.OR.C.001 Organisations involved in the design and/or production of ATM/ANS

equipment
(a) An applicant for, and a holder of, a design and/or production organisation approval for
ATM/ANS equipment shall be entitled to hold or apply to be issued a certificate for the
design and/or production of ATM/ANS equipment.
(b) As regards design activities, an organisation shall:
(1) issue a declaration of design for certain ATM/ANS equipment, as applicable;
(2) issue data and information under its authority within the scope of its terms of
approval as established by the Agency with the following statement: ‘The technical
content of this document is approved under the authority of
EASA.AOA.GND.[XXXX]’;
(3) prepare and maintain, for each model of each product for which an ATM/ANS
equipment declaration has been issued, a current file of complete technical data and
records.
(c) As regards production activities, an organisation shall:
(1) manufacture each article ensuring that the completed product conforms to its
design data and is safe for installation;
(2) prepare and maintain, for each model of each product for which an ATM/ANS
equipment declaration has been issued, a current file of complete technical data and
records;
(3) prepare, maintain and update the master copies of all manuals required by the
applicable declaration specifications for the particular product;
(4) make available to the users of the product, and to the Agency on request, those
instructions for continued suitability necessary for the use and maintenance of the
product, and changes to those instructions;
(5) mark each article;
(6) continue to comply with the applicable requirements laid down in this Regulation.
8. Appendices
(d) In addition to point (c), an organisation involved in the production of ATM/ANS

equipment shall be entitled to, within the scope of its terms of approval, determine that
each completed ATM/ANS equipment conforms with the applicable design data and is
in a condition for safe operation before issuing a statement of conformity that the
ATM/ANS equipment it has manufactured has been produced in accordance with the
applicable requirements of this Regulation and with the applicable design data.
(e) The statement of conformity referred to in point (d) for each ATM/ANS equipment
manufactured shall contain at least the following information:
(1) a description of the ATM/ANS equipment;
(2) its part number;
(3) its serial number;
(4) a statement that the ATM/ANS equipment has been manufactured in conformity to
the applicable design data and is in a condition for safe operation;
(5) a reference to the declaration of design.
DPO.OR.C.005 Coordination
An organisation involved in the design and/or production of ATM/ANS equipment shall
ensure:
(a) the satisfactory coordination, with the appropriate arrangements, between design and
production activities, as appropriate;
(b) the proper support of the continued suitability of the ATM/ANS equipment, as
applicable;
(c) the proper support to the ATM/ANS equipment design activity with regard to its
continued suitability of the ATM/ANS equipment.
DPO.OR.C.010 ATM/ANS equipment directives

When an ATM/ANS equipment directive has to be issued by the Agency, the organisation
involved in the design and/or production of ATM/ANS equipment shall:
(a) propose an appropriate corrective action and submit it together with details to the Agency
for approval;
(b) following the approval by the Agency of the proposal referred to in point (a), make
available to all known users or owners of ATM/ANS equipment appropriate descriptive
data and accomplishment instructions and, on request, to any person required to comply
with the ATM/ANS equipment directive.
8. Appendices
8.2. Appendix 2: DRAFT COMMISSION DELEGATED REGULATION (EU) …/... laying down
common technical requirements and administrative procedures for the certification
and declaration of compliance of the design of ATM/ANS systems and ATM/ANS
constituents
DRAFT COMMISSION DELEGATED REGULATION (EU) …/...
of XXX
laying down common technical requirements and administrative procedures for the
certification and declaration of compliance of the design of ATM/ANS systems and

Whereas:
(5) [Initial capital…],
Article 1
Subject matter and scope
1. This Regulation lays down, pursuant to Article 47 of Regulation (EU) 2018/1139,
common technical requirements and administrative procedures for the certification and
declaration of compliance of the design of ATM/ANS systems and ATM/ANS
constituents, i.e. ‘ATM/ANS equipment’, specifying:
(a) the identification of ATM/ANS equipment subject to certification, declaration, or
a statement of compliance;
(b) the issue of certificates for ATM/ANS equipment;
(c) the making of a declaration of compliance of the design of ATM/ANS equipment
by an organisation involved in the design and/or production of ATM/ANS
equipment approved in accordance with Implementing Regulation (EU) …/…
[implementing act on DPO approval] to have the privileges to issue such
declarations of compliance;
(d) the issue of a statement of compliance of ATM/ANS equipment by an ATM/ANS
provider certified in accordance with Implementing Regulation (EU) 2017/373;
(e) the issue of ATM/ANS equipment directives by the Agency.
20
OJ L […], […], p. […].
8. Appendices
Article 2
Definitions
For the purpose of this Regulation, ‘ATM/ANS equipment’ means ATM/ANS constituents as
defined by Article 3(6) of Regulation (EU) 2018/1139, and ATM/ANS systems as defined by
Article 3(7) of that Regulation, excluding airborne constituents.
Article 3
Competent authority
3. The competent authority responsible for the issue of certificates for ATM/ANS
equipment in accordance with Article 4 of this Regulation, and for the acceptance of
declarations of compliance of the design of ATM/ANS equipment in accordance with
Article 5 of this Regulation shall be the Agency pursuant to Article 80(2)(c) of Regulation
(EU) 2018/1139. For that purpose, the Agency shall comply with the requirements laid
down in Annex I to this Regulation.
4. The competent authority responsible for the oversight of the statements of compliance
issued by an ATM/ANS provider in accordance with Article 6 of this Regulation shall be
the competent authority responsible for the certification and oversight of that ATM/ANS
provider in accordance with Article 4(1) of Implementing Regulation (EU) 2017/373.
Article 4
Certification of ATM/ANS equipment
1. ATM/ANS equipment that processes and delivers data for the purpose of the provision
of ATM, including equipment that is necessary for the purpose of controller–pilot
communications and for the separation of aircraft and the prevention of collisions, shall
be issued with a certificate by the Agency as specified in Annex II to this Regulation.
2. A certificate for ATM/ANS equipment shall be issued for an unlimited duration. It shall
remain valid subject to the following conditions:
(a) the certificate holder remains in compliance with the requirements of this
Regulation and, for ATM/ANS equipment, continuously demonstrates its
capability by holding an organisation approval issued by the Agency in accordance
with Implementing Regulation (EU) …/… [implementing act on DPO approval];
(b) the certificate holder ensures the continuous compliance of the ATM/ANS
equipment with its certification basis; and
(c) the certificate has not been surrendered by its holder or revoked by the Agency.
3. Upon surrender or revocation of the certificate, if issued in a paper format, it shall be
returned to the Agency without delay.
8. Appendices
Article 5
Declaration of design compliance of the ATM/ANS equipment
1. ATM/ANS equipment which generates, receives, and transmits data and/or signals in
space for the purpose of ensuring safe and interoperable air navigation shall be issued
with a declaration of design compliance as specified in Annex II to this Regulation by an
organisation involved in the design and/or production of ATM/ANS equipment approved
in accordance with Implementing Regulation (EU) …/… [implementing act on DPO
approval] to have the privilege to issue such declarations.
Question 8.2 #1
Stakeholders are invited to comment on whether sensors (for example, PSR/SSR radars, ADS-
B receivers or MLAT equipment) used for surveillance should be subject to declaration by
approved design and/or production organisations, including a justification.
2. A declaration of compliance of the design of the ATM/ANS equipment shall be issued
for an unlimited duration. It shall remain valid unless it has been deregistered in
accordance with point (g)(6) of point ATM/ANS.EQMT.AR.C.020 of Annex I as a result
of the following:
(a) the ATM/ANS equipment no longer complies with the applicable technical
specifications against which the declaration has been made; or
(b) the issuer of the declaration no longer remains in compliance with the applicable
requirements of Implementing Regulation (EU) …/… [implementing act on DPO
approval] or its approval has been surrendered, suspended or revoked; or
(c) the ATM/ANS equipment has proved to give rise to unacceptable risk or
unacceptable performance in service; or
(d) the organisation has withdrawn the declaration of compliance.
Article 6
Statement of compliance
1. ATM/ANS equipment which is neither subject to certification in accordance with
Article 4 of this Regulation nor to a declaration of compliance in accordance with
Article 5 of this Regulation shall be issued with a statement of compliance by the
ATM/ANS provider in accordance with point (g)(3) of point ATM/ANS.OR.A.045 of
Regulation (EU) 2017/373 confirming that the ATM/ANS equipment complies with the
technical standards established by recognised standardisation bodies and listed in
detailed specifications adopted by the Agency in accordance with Article 76(3) of
Regulation (EU) 2018/1139.
2. A statement of compliance for ATM/ANS equipment shall be issued for an unlimited
duration. It shall remain valid unless:
(a) the ATM/ANS equipment no longer complies with the essential requirements set
out in Annex VIII and, if applicable, in Annex VII to Regulation (EU) 2018/1139;
or
(b) the ATM/ANS provider no longer remains in compliance with the applicable
requirements of Implementing Regulation (EU) 2017/373 or it has surrendered the
certificate, or the certificate has been suspended or revoked by the Agency; or
8. Appendices
(c) the ATM/ANS equipment has proved to give rise to unacceptable risk or
unacceptable performance in service; or
(d) the ATM/ANS provider has withdrawn the statement of compliance or
enforcement measures have been taken in accordance with point
ATM/ANS.AR.A.050(e).
Article 7
Transitional provisions
1. The following transitional provisions shall apply to ATM/ANS equipment with EC
declarations issued in accordance with Article 5 or Article 6 of Regulation (EC) No
552/200421 and that has been manufactured or put in operation by an ATM/ANS provider
before the date of entry into force of this Regulation:
(a) ATM/ANS equipment which falls within the category of ATM/ANS equipment
that requires certification in accordance with Article 4 of this Regulation shall, on
a provisional basis, be deemed to have been issued with a certificate in accordance
with Article 4 of this Regulation unless the Agency determines, following the
evaluation referred to in point 2, that such ATM/ANS equipment does not ensure
a level of safety, performance and interoperability equivalent to that required by
Regulation (EU) 2018/1139 and this Regulation;
(b) ATM/ANS equipment which falls within the category of ATM/ANS equipment
that requires declaration in accordance with Article 5 of this Regulation shall, on a
provisional basis, be deemed to have been issued with a declaration of compliance
in accordance with Article 5 of this Regulation unless the Agency determines,
following the evaluation referred to in point 2, that such ATM/ANS equipment
does not ensure a level of safety, performance and interoperability equivalent to
that required by Regulation (EU) 2018/1139 and this Regulation;
(c) as regards ATM/ANS equipment which falls within the category of ATM/ANS
equipment subject to a statement of compliance in accordance with Article 6 of this
Regulation, the EC declarations of verification of systems that have been issued or
recognised in accordance with Article 6 of Regulation (EC) No 552/2004 shall
continue to be valid and shall be deemed to be a statement of compliance pursuant
to Article 6 of this Regulation.
2. The Agency shall evaluate the ATM/ANS equipment referred to in point 1(a) and (b)
within [5 years] from the date of entry into force of this Regulation.
For that purpose, the competent authorities responsible for the certification and oversight
of the ATM/ANS providers referred to in Article 4(1) of Implementing Regulation (EU)
2017/373 shall provide the Agency with the relevant information to facilitate this
evaluation. The objective of that evaluation shall be to determine that the particular
ATM/ANS equipment ensures a level of safety, performance and interoperability
equivalent to that required by Regulation (EU) 2018/1139 and this Regulation.
21 Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European
Air Traffic Management network (the interoperability Regulation) (OJ L 96, 31.3.2004, p. 26)
8. Appendices
3. ATM/ANS equipment that is subject to certification in accordance with Article 4 or a

declaration in accordance with Article 5 of this Regulation and that has been
manufactured from [the date of entry into force of this Regulation] until [12 September
2028] shall be subject to a statement of compliance issued in accordance with Article 6
of this Regulation. With effect from [13 September 2028], the following provisions shall
apply to such ATM/ANS equipment:
(a) ATM/ANS equipment which falls within the category of ATM/ANS equipment
that requires certification in accordance with Article 4 of this Regulation shall, on
a provisional basis, be deemed to have been issued with a certificate in accordance
with Article 4 of this Regulation unless the Agency determines, following the
evaluation referred to in point (c), that such ATM/ANS equipment does not ensure
a level of safety, performance and interoperability equivalent to that required by
Regulation (EU) 2018/1139 and this Regulation;
(b) ATM/ANS equipment which falls within the category of ATM/ANS equipment
that requires a declaration of compliance in accordance with Article 5 of this
Regulation shall, on a provisional basis, be deemed to have been issued with a
declaration of compliance in accordance with Article 5 of this Regulation unless
the Agency determines, following the evaluation referred to in point (c) that such
ATM/ANS equipment does not ensure a level of safety, performance and
interoperability equivalent to that required by Regulation (EU) 2018/1139 and this
Regulation;
(c) The Agency shall evaluate the ATM/ANS equipment referred to in point 3(a) and
(b) until [12 September 2030].
For that purpose, the competent authorities responsible for the certification and
oversight of the ATM/ANS providers referred to in Article 4(1) of Implementing
Regulation (EU) 2017/373 shall provide the Agency with the relevant information
to facilitate this evaluation. The objective of that evaluation shall be to determine
that the particular ATM/ANS equipment meets a level of safety, performance and
interoperability equivalent to that required by Regulation (EU) 2018/1139 and this
Regulation.
Article 8
Entry into force
8. Appendices
Done at Brussels,
For the Commission

The President
[…]
ANNEX I
REQUIREMENTS FOR THE AGENCY
(Part-ATM/ANS.EQMT.AR)
SUBPART A — GENERAL REQUIREMENTS (ATM/ANS.EQMT.AR.A)
ATM/ANS.EQMT.AR.A.005 Scope
This Annex establishes the requirements for the administration and management systems of
the Agency for the certification, registration of declarations, oversight and enforcement of
ATM/ANS equipment when it exercises its tasks and responsibilities set out in Annexes II and
III to this Regulation with regard to:
(a) the issue, maintenance, amendment, limitation, suspension or revocation of certificates
for ATM/ANS equipment;
(b) the acceptance of declarations for ATM/ANS equipment;
(c) the approval, oversight and enforcement in respect of the fulfilment of the requirements
set out in the Annex (Part-DPO.OR) to Implementing Regulation (EU) …/…
[implementing act on DPO approval] by organisations involved in the design and/or
ATM/ANS.EQMT.AR.A.010 Certification, oversight and enforcement documentation

The Agency shall make available to its staff all applicable legislative acts, standards, rules,
technical publications and related documentation to allow them to perform their tasks and
discharge their responsibilities.
ATM/ANS.EQMT.AR.A.015 Exchange of information between the competent

authorities and the Agency
(a) The competent authorities referred to in Article 4 of Implementing Regulation (EU)
2017/373 and the Agency shall exchange the information which is available to them
through their investigations conducted and oversight performed, and which is relevant
for the other party when performing certification, oversight or enforcement tasks under
this Regulation.
(b) The competent authority of the Member State referred to in Article 4(1) of Implementing
Regulation (EU) 2017/373 and the Agency shall coordinate a product-focused
investigation and oversight of the ATM/ANS equipment designed and produced in
accordance with this Regulation, including, where necessary, the performance of joint
oversight visits.
8. Appendices
ATM/ANS.EQMT.AR.A.020 Means of compliance

(a) The Agency shall develop acceptable means of compliance (AMC) that may be used by
persons or organisations to demonstrate compliance with Regulation (EU) 2018/1139
and the delegated and implementing acts adopted on its basis. When the acceptable means
of compliance is/are complied with, the applicable requirements of Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on its basis shall be deemed
to have been met.
(b) Other, alternative means of compliance (AltMoC) may be used by an organisation
involved in the design and/or production of ATM/ANS equipment to establish
compliance with Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on its basis.
(c) The Agency shall evaluate all AltMoC proposed by an organisation involved in the
design and/or production of ATM/ANS equipment in accordance with point
DPO.OR.A.015 of the Annex to Implementing Regulation (EU) …/… [implementing act
on DPO approval] by analysing the documentation provided and, if considered
necessary, conducting an inspection of the ATM/ANS provider.
(d) When the Agency finds that the AltMoC proposed by an applicant is/are sufficient to
establish compliance with the applicable requirements, it shall without undue delay
notify the applicant that the proposed AltMoC may be implemented and, if applicable,
amend the approval of the applicant accordingly.
ATM/ANS.EQMT.AR.A.025 Immediate reaction to a safety and interoperability

problem
(a) Without prejudice to Regulation (EU) No 376/2014 and the delegated and implementing
acts adopted on its basis, the Agency shall implement a system to appropriately collect,
analyse, and disseminate safety and interoperability information.
(b) Upon receiving the information referred to in point (a), the Agency shall take appropriate
measures to address the safety and/or interoperability problem, including the issue of
ATM/ANS equipment directives in accordance with point ATM/ANS.EQMT.AR.A.025.
(c) The measures taken under point (b) shall immediately be notified to the organisation
concerned to comply with them, in accordance with point DPO.OR.A.035 of the Annex
to Implementing Regulation (EU) …/… [implementing act on DPO approval]. When
joint action is required, the competent authorities of the ATM/ANS providers concerned
shall also be notified.
ATM/ANS.EQMT.AR.A.030 ATM/ANS equipment directives

(a) ‘ATM/ANS equipment directive’ means a document issued by the Agency, which
mandates actions to be performed by ATM/ANS providers on ATM/ANS equipment to
address an unsafe condition that has been identified and restore the performance and
interoperability of that ATM/ANS equipment when evidence shows that the safety,
performance or interoperability of that particular equipment may otherwise be
compromised.
8. Appendices
(b) The Agency shall issue an ATM/ANS equipment directive when:

(1) an unsafe, underperformance or non-interoperability condition has been
determined by the Agency to exist in the equipment as a result of a deficiency in
the equipment; and
(2) that condition is likely to exist or develop in other ATM/ANS equipment.
(c) When an ATM/ANS equipment directive is issued to correct the condition referred to in
point (b), the holder of the ATM/ANS equipment certificate or the declarant of the
declaration of compliance of the ATM/ANS equipment design shall, unless otherwise
determined by the Agency in case urgent action is needed:
(1) propose appropriate corrective action and submit details of that proposal to the
Agency for approval;
(2) following the approval by the Agency of the proposal referred to in point (1), make
available to all known users of the equipment and, on request, to any person
required to comply with the ATM/ANS equipment directive, appropriate
descriptive data and accomplishment instructions.
(d) An ATM/ANS equipment directive shall contain at least the following information:
(1) identification of the unsafe, underperformance or non-interoperability condition;
(2) the affected ATM/ANS equipment;
(3) the required action(s) and the rationale;
(4) the accomplishment time for the required action(s);
(5) the date of entry into force.
(e) The verification of compliance of the organisations with the applicable ATM/ANS
equipment directives shall be ensured by the competent authorities of the ATM/ANS
providers that use the affected ATM/ANS equipment, as applicable.
ATM/ANS.EQMT.AR.A.035 ATM/ANS equipment certification basis

(a) The Agency shall establish the ATM/ANS equipment certification basis and notify it to
the applicant for an ATM/ANS equipment certificate. The certification basis shall consist
of the following:
(1) detailed certification specifications issued by the Agency in accordance with
Article 76(3) of Regulation (EU) 2018/1139 and point
ATM/ANS.EQMT.AR.A.035 of this Annex, which are applicable to the
ATM/ANS equipment on the date of submission of the application for that
certificate, unless:
(i) the applicant chooses to comply or is required to comply as per point
ATM/ANS.EQMT.CERT.015(e) with a certification specification which
became applicable after the date of the submission of the application; if the
applicant chooses to comply with a certification specification which became
applicable after the date of the submission of the application, the Agency
shall include it in the ATM/ANS equipment certification basis; or
8. Appendices
(ii) the Agency accepts any alternative to a determined certification specification

that cannot be complied with, for which compensating factors have been
found to ensure equivalence with the applicable certification or declaration
specification(s); and
(2) any special conditions prescribed by the Agency in accordance with point
ATM/ANS.EQMT.AR.A.040.
(b) The inclusion of additional features, characteristics or functions not initially included in
the certification basis shall be agreed by the Agency.
(c) The applicant shall demonstrate that the features, characteristics or functions that do not
form part of the certification basis have no interference or detrimental effect on the
useability of the ATM/ANS equipment.
ATM/ANS.EQMT.AR.A.040 Detailed specifications for the equipment design

compliance
(a) The Agency, in accordance with Article 76(3) of Regulation (EU) 2018/1139, shall
establish and make available detailed technical specifications which organisations may
use to demonstrate compliance with the relevant essential requirements set out in
Annex VIII and, if applicable, Annex VII to that Regulation when they:
(1) apply for the certification of ATM/ANS equipment in accordance with Annex II to
this Regulation;
(2) declare compliance of ATM/ANS equipment in accordance with Annex III to this
Regulation;
(3) make a statement of compliance in accordance with Article 6 of this Regulation
and with point ATM/ANS.OR.A.045 of Regulation (EU) 2017/373.
(b) The detailed technical specifications referred to in point (a) shall provide design
standards which reflect the state of the art and best design practices, and which build on
valuable experience gained and scientific and technical progress, and on the best
available evidence and analyses as regards ATM/ANS equipment.
ATM/ANS.EQMT.AR.A.045 Special conditions

(a) The Agency shall prescribe additional requirements, named ‘special conditions’, for
ATM/ANS equipment if the related applicable certification specifications are not deemed
adequate because:
(1) the ATM/ANS equipment has novel or unusual design features relative to the
design practices on which the applicable certification specifications are based;
(2) the intended use of the ATM/ANS equipment is unconventional;
(3) experience with other similar ATM/ANS equipment in service having similar
design features or newly identified risks has shown that unwanted conditions may
develop; or
8. Appendices
(4) the environment at the location of installation physically prevents the fulfilment of
certain requirements of the applicable certification specifications;
(b) Special conditions contain safety, performance, security, and interoperability standards
the Agency finds necessary to ensure the appropriate level of performance of the
ATM/ANS equipment equivalent to that required by the applicable certification
specifications.
ATM/ANS.EQMT.AR.A.050 Level of involvement
(a) The Agency shall determine its level of involvement in the verification of compliance-
demonstration activities and data related to an application for the issue of a certificate or
for changes to it. It shall determine it based on the assessment of subjective groups of
compliance-demonstration activities and data from the certification programme.
The assessment shall address the following:
(1) the likelihood of an unidentified non-compliance with the certification basis; and
(2) the potential impact of that non-compliance on safety, service specifications and
functioning of the ATM/ANS equipment,
and consider at least the following elements:
(i) novel or unusual features of the certification project, including operational,
organisational and knowledge-management aspects;
(ii) complexity of the design and/or the demonstration of compliance;
(iii) criticality of the design or the technology, the related safety or service-
compliance risks and the functioning of the ATM/ANS equipment, including
those identified on similar designs; and
(iv) performance and experience of the applicant in the domain concerned.
(b) The Agency shall notify its level of involvement to the applicant and shall update its level
of involvement when this is warranted by information which has an appreciable impact
on the risk previously assessed in accordance with point (a). The Agency shall notify the
applicant about any change to the level of involvement.
ATM/ANS.EQMT.AR.A.055 Issue of an ATM/ANS equipment certificate

(a) The Agency shall issue a certificate for ATM/ANS equipment, provided that:
(1) the applicant has demonstrated compliance with point
ATM/ANS.EQMT.CERT.015;
(2) the Agency, through the verification of the demonstration of compliance in
accordance with its level of involvement determined in accordance with point
ATM/ANS.EQMT.AR.A.050, has not identified any non-compliance with the
certification basis; and
8. Appendices
(3) no feature or characteristic has been identified that may render the equipment
unsafe for the intended use.
(b) The ATM/ANS equipment certificate shall include the operating limitations, the data
sheet for continued suitability, the applicable ATM/ANS equipment certification basis
with which the Agency records compliance, and any other conditions or limitations
prescribed for the product in the applicable certification specifications and special
conditions.
ATM/ANS.EQMT.AR.A.060 Declaration of compliance of the ATM/ANS equipment

design
(a) Upon receiving a declaration of compliance for ATM/ANS equipment design from an
organisation involved in the design of ATM/ANS equipment approved by the Agency in
accordance with Implementing Regulation (EU) …/… [implementing act on DPO
approval] and which has the privilege under that approval to make such declarations, the
Agency shall verify that:
(1) the declaration contains all the information specified in point
ATM/ANS.EQMT.DEC.010;
(2) no feature or characteristic has been identified that may render the ATM/ANS
equipment unsafe for the intended use.
(b) The ATM/ANS equipment design compliance declaration shall include the operating
limitations, the data sheet for continued suitability, the applicable specifications with
which the organisation has recorded compliance, and any other conditions or limitations
prescribed for the product in the applicable certification specifications and special
conditions.
(c) If the declaration is not consistent with the organisation’s privileges or contains
information that indicates non-compliance with the applicable declaration specification,
the Agency shall notify the organisation concerned about the non-compliance and request
further information, corrective actions, and evidence.
(d) The Agency shall register the declaration provided that the requirements in points (a) to
(c) are met. The Agency shall maintain a register of all valid compliance declarations as
regards ATM/ANS equipment submitted to it in accordance with this Regulation.
ATM/ANS.EQMT.AR.A.065 Issue of approvals to organisations involved in the design

and/or production of ATM/ANS equipment
(a) Upon receiving an application for the issue of an approval to an organisation involved in
the design and/or production of ATM/ANS equipment, the Agency shall verify the
organisation’s compliance with the applicable requirements laid down in Annex II, III or
IV to this Regulation.
(b) The Agency may request any audits, inspections or assessments it finds necessary before
issuing the approval with all the relevant information set out in Appendix 1 to this Annex.
(c) The approval shall be issued for an unlimited duration. The privileges as regards the
activities the organisation is approved to conduct shall be specified in the conditions
attached to the approval.
8. Appendices
(1) With regard to an organisation involved in the design of ATM/ANS equipment, the
conditions shall specify the type of design work and the categories of ATM/ANS
equipment for which the organisation holds an approval, and the privileges the
organisation is approved to exercise.
(2) With regard to an organisation involved in the production of ATM/ANS
equipment, the conditions shall specify the scope of work and the ATM/ANS
equipment or the equipment categories, or both, for which the certificate holder is
entitled to exercise the privileges.
(d) The certificate shall not be issued where a level 1 finding remains open. In exceptional
circumstances, finding(s) other than level 1 shall be assessed and mitigated as necessary
by the organisation and a corrective action plan for closing the finding(s) shall be
approved by the Agency prior to the issue of the certificate.
(e) Each change to the approval and to its conditions shall be approved by the Agency.
SUBPART B — MANAGEMENT (ATM/ANS.EQMT.AR.B)
ATM/ANS.EQMT.AR.B.001 Management system

(a) The Agency shall establish and maintain a management system, including, as a
minimum, the following elements:
(1) documented policies and procedures to describe its organisation, means and
methods to establish compliance with Regulation (EU) 2018/1139 and Regulation
(EU) No 376/2014 and the delegated and implementing acts adopted on their bases,
as necessary, for the exercise of its certification, oversight and enforcement tasks;
the procedures shall be kept up to date and serve as the basic working documents
within the Agency for all related tasks;
(2) a sufficient number of personnel to perform its tasks and discharge its
responsibilities under this Regulation; a system shall be in place to plan the
availability of personnel in order to ensure the proper completion of all related
tasks;
(3) personnel that are qualified to perform their allocated tasks and have the necessary
knowledge and experience, and have received initial and recurrent training to
ensure their continuing competence.
(4) adequate facilities and offices to perform the allocated tasks;
(5) a function to monitor the compliance of the management system with the relevant
requirements and the adequacy of the procedures, including the establishment of
an internal audit process and a safety risk management process; the compliance-
monitoring function shall include a system to provide feedback about audit findings
to the senior management of the Agency to ensure the implementation of corrective
actions as necessary;
(6) a person or group of persons ultimately responsible to the senior management of
the Agency for the compliance-monitoring function.
(b) The Agency shall, for each field of activity included in the management system, appoint
one or more persons with the overall responsibility for the management of the relevant
task(s).
8. Appendices
(c) The Agency shall establish procedures for its participation in a mutual exchange of all
the necessary information with any other competent authority(ies) referred to in Article
4 of Implementing Regulation (EU) 2017/373 and provide them with assistance,
including any information that stems from mandatory and voluntary occurrence reporting
as required by point DPO.OR.A.040 of the Annex to Implementing Regulation (EU)
…/… [implementing act on DPO approval].
ATM/ANS.EQMT.AR.B.005 Allocation of tasks to qualified entities

(a) The Agency may allocate its tasks related to the certification or the continuing oversight
of organisations subject to Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on its basis to qualified entities. When allocating its tasks, the
Agency shall ensure that it has:
(1) put a system in place to initially and continuously assess that the qualified
entity(ies) complies (comply) with Annex VI to Regulation (EU) 2018/1139; this
system and the results of the assessments shall be documented;
(2) established and documented an agreement with the qualified entity(ies), approved
by both parties at the appropriate management level, which clearly defines:
(i) the tasks to be performed;
(ii) the declarations, reports and records to be provided;
(iii) the technical conditions to be met when performing the tasks;
(iv) the related liability coverage; and
(v) the protection given to information acquired when carrying out the tasks.
(b) The Agency shall ensure that the internal audit process and the safety risk management
process required by point ATM/ANS.EQMT.AR.B.001(a)(4) cover all the tasks
performed on its behalf by the qualified entity(ies).
ATM/ANS.EQMT.AR.B.010 Changes in the management system

(a) The Agency shall have a system in place to identify those changes that affect its capability
to perform its tasks and discharge its responsibilities as defined in Regulation (EU)
2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts
adopted on their bases. That system shall enable the Agency to take action, as
appropriate, to ensure that the management system remains adequate and effective.
(b) The Agency shall update its management system to reflect any changes to Regulation
(EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing
acts adopted on their bases, in a timely manner, so as to ensure the effective
implementation of its management system.
ATM/ANS.EQMT.AR.B.015 Record-keeping
(a) The Agency shall establish a record-keeping system that provides for adequate storage,
accessibility, and reliable traceability of:
(1) the management system’s documented policies and procedures;
(2) the training, qualifications, and authorisation of personnel as required by point
ATM/ANS.EQMT.AR.B.001(a)(2);
8. Appendices
(3) the allocation of tasks, covering the elements required by point

ATM/ANS.EQMT.AR.B.005, as well as the details of the allocated tasks;
(4) the approval process as regards organisations involved in the design and/or
production of ATM/ANS equipment, the certification process, and the registration
of declarations of design compliance for ATM/ANS equipment and the continuing
oversight, including:
(1) applications for the issue of approvals;
(2) approvals issued to organisations involved in the design and/or production of
ATM/ANS equipment, including the associated privileges and any changes
to them;
(3) ATM/ANS equipment certificates issued, including any changes to them;
(4) declarations of compliance of ATM/ANS equipment design;
(5) the Agency’s continuing oversight programme, including all assessment,
audit and inspection records;
(6) a copy of the oversight programme listing the dates when audits are due and
when audits were carried out;
(7) copies of all formal correspondence;
(8) recommendations for the issue or continuation of a certificate or continuation
of the registration of a declaration, details of findings, and actions taken by
the organisations to close them, including the date of closure of each item,
enforcement actions, and observations;
(9) any assessment, audit or inspection report;
(10) copies of all organisation handbooks, procedures and processes or manuals
and amendments to them;
(11) copies of any other documents approved by the Agency;
(5) the notification and evaluation of the AltMoC proposed by organisations involved
in the design and/or production of ATM/ANS equipment and the assessment of
these AltMoC;
(6) safety information, ATM/ANS equipment directives, and follow-up measures;
(7) the use of flexibility provisions pursuant to Article 76(4) of Regulation (EU)
2018/1139.
(b) The Agency shall maintain a list of all the certificates it has issued and of any declarations
it has registered.
(c) All the records referred to in points (a) and (b) shall be kept for a minimum period of
5 years, subject to the applicable data protection law.
(d) All the records referred to in points (a) and (b) shall be made available upon request to
the competent authorities referred to in Article 4 of Implementing Regulation (EU)
2017/373.
8. Appendices
SUBPART C — OVERSIGHT, CERTIFICATION AND ENFORCEMENT

(ATM/ANS.EQMT.AR.C)
ATM/ANS.EQMT.AR.C.001 Initial oversight investigation

(a) Upon receiving a declaration of compliance of the ATM/ANS equipment design from an
organisation involved in its design and/or production, the Agency shall verify that:
(1) the declarant has the privilege to declare design compliance in accordance with
point ATM/ANS.EQMT.DEC.005;
(2) the declaration contains all the information specified in point
ATM/ANS.EQMT.DEC.010; and
(3) the declaration does not contain information that indicates a non-compliance with
the applicable requirements of Annex III to this Regulation.
(b) The Agency shall acknowledge the receipt of the declaration, including the assignment
of an individual declared production organisation reference number to the declarant.
ATM/ANS.EQMT.AR.C.005 Registration of a declaration of design compliance of

ATM/ANS equipment
The Agency shall register a declaration of design compliance in a suitable database, provided
that:
(a) the declarant has declared compliance of the ATM/ANS equipment design in accordance
with point ATM/ANS.EQMT.DEC.010;
(b) the declarant has committed to undertake the obligations laid down in Annex III to this
Regulation;
(c) there are no unresolved issues in accordance with point ATM/ANS.EQMT.AR.C.001.
ATM/ANS.EQMT.AR.C.010 Oversight programme

(a) The Agency shall establish and update annually an oversight programme taking into
account the specific nature of the organisations it oversees, the complexity of their
activities, and the results of past certification and/or oversight activities, and shall base it
on the assessment of the associated risks. The oversight programme shall include audits,
which shall:
(1) cover all the areas of potential concern, with a focus on those areas where problems
have been identified in the past;
(2) cover all the organisations under the Agency’s oversight;
(3) cover the means implemented by the organisations to ensure the competence of
their personnel;
(4) ensure that audits are conducted in a manner commensurate with the level of the
risk posed by the organisation’s activities; and
(5) ensure that for organisations under its supervision, an oversight planning cycle not
exceeding 24 months is applied.
The oversight planning cycle may be reduced if there is evidence that the safety
performance of the organisation has decreased.
8. Appendices
The oversight planning cycle may be extended to a maximum of 36 months if the

Agency has established that during the previous 24 months:
(i) the organisation has continuously demonstrated compliance with the change
management requirements under point DPO.OR.B.005 of the Annex to
Implementing Regulation (EU) …/… [implementing act on DPO approval];
(ii) no level 1 findings have been issued;
(iii) all corrective actions have been implemented within the time period accepted
or extended by the Agency as defined in point ATM/ANS.EQMT.AR.C.010.
If, in addition to the above, the organisation has established an effective
continuous reporting system to the Agency as regards its regulatory compliance,
which has been approved, the oversight planning cycle may be extended to a
maximum of 48 months;
(6) ensure the follow-up of the implementation of corrective actions;
(7) be subject to consultation with the organisations concerned and thereafter its
notification;
(8) indicate the planned intervals of the inspections of the different sites, if any.
(b) The Agency may decide to modify the objectives and the scope of the preplanned audits,
including documentary reviews and additional audits, wherever that need arises.
(c) The Agency shall decide which arrangements, elements, physical locations, and activities
are to be audited within a specified time frame.
(d) Audit observations and findings issued in accordance with point
ATM/ANS.EQMT.AR.C.020 shall be documented.
(e) The findings shall be supported by evidence and identified in terms of applicable
requirements and their implementation arrangements against which the audit has been
conducted.
(f) An audit report, including the details of findings and observations, shall be prepared and
communicated to the organisation concerned.
ATM/ANS.EQMT.AR.C.015 Changes to declarations

(a) Upon receiving a notification of changes in accordance with point
ATM/ANS.EQMT.DEC.015, the Agency shall verify the completeness of the
notification in accordance with point ATM/ANS.EQMT.AR.C.001.
(b) When the change(s) affects (affect) any aspect of the declaration that is registered in
accordance with point ATM/ANS.EQMT.AR.C.005, the Agency shall update the
register.
(c) Upon completion of the activities required by points (a) and (b), the Agency shall
acknowledge receipt of the notification to the organisation involved in the design and/or
8. Appendices
ATM/ANS.EQMT.AR.C.020 Findings, corrective actions, and enforcement measures

(a) When the Agency, during investigation or oversight or by any other means, identifies a
non-compliance with the applicable requirements of Regulation (EU) 2018/1139 and the
delegated and implementing acts adopted on its basis of a procedure or manual required
by that Regulation, or of a certificate or declaration issued in accordance with that
Regulation, it shall, without prejudice to any additional action required by that
Regulation, raise a finding.
(b) The Agency shall have a system in place to analyse findings for their safety and
interoperability significance and identify appropriate enforcement measures, including
the suspension or revocation of approvals and certificates, and issue directives on the
basis of the risk posed by the organisation’s non-compliance.
(c) A level 1 finding shall be raised by the Agency when any significant non-compliance is
identified which may lead to an uncontrolled non-compliance and to a potential unwanted
condition as per point ATM/ANS.EQMT.AR.A.025.
Level 1 findings shall include but are not limited to:
(1) the promulgation of operational procedures which introduce a significant risk to
the organisation’s activities;
(2) the obtainment or maintenance of the validity of the organisation’s approval
through the submission of falsified documentary evidence;
(3) evidence of malpractice or fraudulent use of the organisation’s approval;
(4) the lack of an accountable manager.
(d) A level 2 finding shall be raised by the Agency when any other non-compliance is
identified with the applicable requirements of Regulation (EU) 2018/1139 and the
delegated and implementing acts adopted on its basis, with the procedures and manuals
required by that Regulation, or with the approval issued in accordance with that
Regulation, which is not classified as level 1 finding.
(e) When a finding is raised, during oversight or by any other means, the Agency shall,
without prejudice to any additional action required by Regulation (EU) 2018/1139 and
the delegated and implementing acts adopted on its basis, communicate the finding to the
organisation concerned in writing and require it to take corrective action to address the
non-compliance(s) identified.
(1) In the case of level 1 findings, the Agency shall immediately take appropriate
enforcement measures and may, if appropriate, limit, suspend or revoke in whole
or in part the approval until successful corrective action has been taken by the
organisation.
(2) In the case of level 2 findings, the Agency shall:
(i) grant the organisation a corrective action implementation period included in
an action plan appropriate to the nature of the finding;
(ii) assess the corrective action and implementation plan proposed by the
organisation, and if the assessment concludes that they are sufficient to
address the non-compliance(s), accept them.
(3) In the case of level 2 findings, where the organisation fails to submit a corrective
action plan that is acceptable to the Agency in the light of the finding, or where the
organisation fails to perform the corrective action within the period of time
8. Appendices
accepted or extended by the Agency, the finding may be raised to a level 1 finding
and action shall be taken in accordance with point (e)(1).
(f) For those cases where level 1 and level 2 findings are not required, the Agency may issue
observations.
(g) The Agency shall:
(1) suspend a certificate if it considers that there are reasonable grounds that such
action is necessary to prevent a credible threat to the safety, performance or
interoperability of ATM/ANS equipment;
(2) issue an ATM/ANS equipment directive under the conditions of point
ATM/ANS.EQMT.AR.A.025;
(3) suspend, revoke or limit a certificate if such action is required in accordance with
point (c);
(4) take immediate and appropriate action that is necessary to limit or prohibit the
activities of an organisation or a natural or legal person if it considers that there are
reasonable grounds that such action is necessary to prevent a credible threat to
ATM/ANS equipment;
(5) not register a declaration of design compliance as long as there are unresolved
findings from the initial oversight investigation;
(6) temporarily or permanently deregister a declaration of design compliance if it
considers that there are reasonable grounds that such action is necessary to prevent
a credible threat to the safety, performance or interoperability of ATM/ANS
equipment;
(7) take any further enforcement measures which are necessary to ensure that a non-
compliance with the essential requirements of Annex VIII and, if applicable,
Annex VII to Regulation (EU) 2018/1139 and with this Annex is rectified and,
where necessary, mitigate its consequences.
(h) Upon taking enforcement measures in accordance with point (g), the Agency shall notify
it to the addressee, state the reasons for it, and inform the addressee of its right to appeal.
8. Appendices
Appendix 1
SPECIFICATIONS OF THE APPROVAL OF AN ORGANISATION INVOLVED IN THE

DESIGN AND/OR PRODUCTION OF ATM/ANS EQUIPMENT
The approval shall specify:
(a) the Agency as the competent authority that issues the approval;
(b) the applicant’s name and postal address;
(c) the applicant’s scope of work;
(d) the location where the activities are to be performed;
(e) the associated privileges for which the applicant has been approved;
(f) a statement of the applicant’s conformity and compliance with the applicable
requirements;
(g) the date of issue and the validity of the approval; and
(h) the additional conditions and/or limitations attached to it.
8. Appendices
ANNEX II
ATM/ANS EQUIPMENT CERTIFICATES
(Part-ATM/ANS.EQMT.CERT)
ATM/ANS.EQMT.CERT.001 Scope
This Annex establishes the procedures for the issue of certificates for ATM/ANS equipment,
and the rights and obligations of the applicant for, and holder of, those certificates.
ATM/ANS.EQMT.CERT.005 Eligibility
Any natural or legal person who has demonstrated, or is in the process of demonstrating, their
design capability in accordance with point ATM/ANS.EQMT.CERT.010, may apply for the
issue of an ATM/ANS equipment certificate under the conditions laid down in this Subpart.
ATM/ANS.EQMT.CERT.010 Demonstration of compliance

An applicant for an ATM/ANS equipment certificate shall hold a design organisation approval
issued by the Agency in accordance with Implementing Regulation (EU) …/… [implementing
act on DPO approval] that covers the respective ATM/ANS equipment.
ATM/ANS.EQMT.CERT.015 Application for an ATM/ANS equipment certificate

(a) An application for an ATM/ANS equipment certificate, or for changes to it, shall be made
in a form and manner established by the Agency.
(b) An application for an ATM/ANS equipment certificate shall include, as a minimum:
(1) preliminary descriptive data of the ATM/ANS equipment and its intended use;
(2) a certification programme for the demonstration of compliance in accordance with
point ATM/ANS.EQMT.CERT.025, consisting of:
(i) a detailed description of the design, including all the configurations to be
certified;
(ii) the proposed equipment characteristics and limitations;
(iii) the intended use of the ATM/ANS equipment;
(iv) a proposal for the initial certification basis, including applicable certification
specifications, proposed special conditions, proposed equivalent safety
findings, as well as a proposed means of compliance and proposed
deviations, as applicable, prepared in accordance with the requirements and
options specified in point ATM/ANS.EQMT.AR.A.030;
(v) a proposal for a breakdown of the certification programme into subjective
groups of compliance-demonstration activities and data, including a proposal
for the means of compliance and related compliance-demonstration
documents;
(vi) a proposal for the assessment of the subjective groups of compliance-
demonstration activities and data, addressing the likelihood of an
unidentified non-compliance with the certification-basis requirements and
the potential impact of that non-compliance on the ATM/ANS equipment;
the proposed assessment shall take into account at least the elements set out
in points (a)(2)(i) to (iv) of point ATM/ANS.EQMT.AR.A.050; based on this
assessment, the application shall include a proposal for the Agency’s level of
8. Appendices
involvement in the verification of the compliance-demonstration activities

and data; and
(vii) a project schedule including the major milestones.
(c) Following the initial submission of the application to the Agency, the applicant shall
update the certification programme when there are changes to the certification project
that affect any of points (b)(i) to (vii).
(d) An application for the issue of an ATM/ANS equipment certificate shall be valid for 5
years unless the applicant demonstrates at the time of the application that it requires a
longer period of time to demonstrate compliance of its product and the Agency agrees to
extend that period of time.
(e) In the case where an ATM/ANS equipment certificate has not been issued, or it is evident
that it will not be issued, within the time limit provided for in point (d), the applicant
may:
(1) submit a new application and comply with the certification-basis requirements, as
established and notified by the Agency in accordance with point
ATM/ANS.EQMT.AR.A.030 for the date of submission of the new application; or
(2) apply for an extension of the time limit provided for in point (d) and propose a new
date for the issue of the certificate; in that case, the applicant shall comply with the
certification-basis requirements, as established and notified by the Agency in
accordance with point ATM/ANS.EQMT.AR.A.030 for a date to be selected by
the applicant; however, that date shall not precede the new date proposed by the
applicant for the issue of the certificate by more than 5 years for an application for
the issue of an ATM/ANS equipment certificate.
ATM/ANS.EQMT.CERT.020 Changes that require the issue of a new ATM/ANS

equipment certificate
An approved design organisation that proposes changes to ATM/ANS equipment shall apply
for the issue of a new certificate if the Agency finds that the changes in the design or the
functionality of that ATM/ANS equipment are so extensive that a substantially complete
investigation of compliance with the applicable certification basis is required.
ATM/ANS.EQMT.CERT.025 Demonstration of compliance with the ATM/ANS

equipment certification basis
(a) An applicant shall, following the acceptance of the certification programme by the
Agency, demonstrate compliance with the ATM/ANS equipment certification basis as
established and notified to the applicant by the Agency in accordance with point
ATM/ANS.EQMT.AR.A.030, and shall provide the Agency with the means by which
such compliance has been demonstrated.
(b) An applicant for an ATM/ANS equipment certificate shall update the certification
programme with the updated certification basis in case the Agency identifies the need for
the applicant to do so following the initial submission established in accordance with
point ATM/ANS.EQMT.AR.A.015.
(c) An applicant shall report to the Agency any difficulty or event encountered during the
process of demonstration of compliance that may have an appreciable effect on the risk
assessment under point ATM/ANS.EQPT.CERT.015(a)(2)(vi) or on the certification
programme or may otherwise require a change to the level of involvement of the Agency
8. Appendices
previously notified to the applicant in accordance with point

ATM/ANS.EQMT.AR.A.050(b).
(d) An applicant shall record justifications of compliance within the compliance documents
as referred to in the certification programme.
(e) Upon completion of all compliance-demonstration activities in accordance with the
certification programme, including any inspections and tests carried out in accordance
with point ATM/ANS.EQMT.CERT.035, an applicant shall declare and submit in a form
and manner established by the Agency that:
(1) it has demonstrated compliance with the certification basis, as established and
notified by the Agency, following the certification programme as accepted by the
Agency in accordance with point (a); and
(2) no feature or characteristic has been identified that may render the ATM/ANS
equipment unsuitable for its intended use.
ATM/ANS.EQMT.CERT.030 ATM/ANS equipment design

(a) The ATM/ANS equipment design shall consist of:
(1) the drawings and specifications, and a listing of those drawings and specifications,
necessary to define the configuration and the design features shown to comply with
the certification basis;
(2) information on the processes and methods of manufacture and assembly of the
product necessary to ensure the conformity of the ATM/ANS equipment;
(3) an approved limitations section of the instructions for continued suitability as
defined by the applicable certification specifications; and
(4) any other data that allows by comparison the determination of the suitability of the
design.
(b) Each design shall be adequately identified.
ATM/ANS.EQMT.CERT.035 Inspection and testing

(a) Before each test is undertaken during the demonstration of compliance required by point
ATM/ANS.EQMT.CERT.025, the applicant shall have verified:
(1) for the test specimen, that:
(i) the standard parts, elements, coding and processes adequately conform to the
specifications for the proposed design;
(ii) the developed ATM/ANS equipment adequately conforms to the proposed
design; and
(iii) the manufacturing processes, construction and assembly adequately conform
to those specified in the proposed equipment design; and
(2) for the test and the measuring equipment to be used for the test, that those are
adequate for the test and appropriately calibrated.
(b) On the basis of the verifications carried out in accordance with point (a), the applicant
shall issue a statement of verification listing any potential non-conformity, together with
8. Appendices
a justification that this will not affect the test results and shall allow the Agency to
perform any inspection it considers necessary to check the validity of that statement.
(c) The applicant shall allow the Agency to:
(1) review any data and information related to the demonstration of compliance; and
(2) witness or carry out any test or inspection conducted for the purpose of
demonstration of compliance.
(d) For all the tests and inspections witnessed by the Agency:
(1) the applicant shall submit to the Agency a statement of validation in accordance
with point (b); and
(2) no change that affects the validity of the statement of validation shall be made to
the test specimen, or the test and measuring equipment, between the time the
statement of conformity provided for in point (b) was issued and the time the test
specimen is presented to or witnessed by the Agency for testing.
ATM/ANS.EQMT.CERT.040 Record-keeping
Further to the record-keeping requirements appropriate to or associated with the management
system, all relevant design information, drawings and test reports, including inspection records
and tests recorded, shall be made available by the certificate holder to the Agency and shall be
retained in order to provide the information necessary to ensure the continued compliance.
ATM/ANS.EQMT.CERT.045 Manuals
The holder of an ATM/ANS equipment certificate shall produce, maintain and update master
copies of all manuals required by the applicable certification basis, and provide copies, on
request, to the Agency.
ATM/ANS.EQMT.CERT.050 Maintenance instructions

(a) The holder of an ATM/ANS equipment certificate shall furnish at least one set of
complete maintenance instructions, comprising descriptive data and accomplishment
instructions prepared in accordance with the applicable certification basis, to all known
users and shall make them available on request to any other person that is required to
comply with any of these maintenance instructions.
(b) Changes to the maintenance instructions shall be made available to all known users and
shall be made available on request to any person that is required to comply with any of
these maintenance instructions. A programme that shows how changes to the
maintenance instructions are made available to all known users shall be submitted to the
Agency.
8. Appendices
ATM/ANS.EQMT.CERT.055 Changes to the ATM/ANS equipment certification basis

(a) The holder of an ATM/ANS equipment certificate shall have a system in place to identify
the scope of the changes to ATM/ANS equipment as ‘minor’ and ‘major’.
(b) All other changes shall be approved by the Agency once the certificate holder
demonstrates that the changes, and the areas affected by the changes, comply with the
certification basis as established by the Agency in accordance with point
ATM/ANS.EQMT.AR.A.035.
(c) By way of derogation from point (b), the changes within the scope of the organisation’s
privileges following the approved procedure shall be managed by the approved design
organisation and shall be limited to specific configuration(s) of the ATM/ANS equipment
to which the changes relate. The changes shall be issued with a statement as per point
(b)(2) of point DPO.OR.C.001 of the Annex (Part-DPO.OR) to Implementing Regulation
(EU) …/… [implementing act on DPO approval].
(d) The part number scheme defined by the approved design organisation shall allow the part
number evolution resulting from the introduction of changes as per point (c).
ATM/ANS.EQMT.CERT.060 Inspections performed by the Agency

Upon the Agency’s request, each organisation that holds a certificate issued by the Agency
under this Annex shall:
(a) grant the Agency access to any facility, product, part, document, record, data, process,
procedure or any other material, and allow the Agency to review any report, make any
inspection and perform or witness any test that is necessary to verify the compliance of
the organisation with the applicable requirements of this Annex;
(b) if the natural or legal person employs partners, suppliers or subcontractors, make
arrangements with them to ensure that the Agency has access to them and may investigate
as described in point (a).
8. Appendices
ANNEX III
DECLARATION OF COMPLIANCE OF THE ATM/ANS EQUIPMENT DESIGN
ATM/ANS.EQMT.DEC.001 Scope
This Annex establishes the procedures for declaring compliance of the ATM/ANS equipment
design, and establishes the rights and obligations of organisations involved in the design of
ATM/ANS equipment that have the privilege to make such declarations.
ATM/ANS.EQMT.DEC.005 Eligibility and demonstration of compliance

An organisation involved in the design of ATM/ANS equipment shall demonstrate its
capability to declare the compliance of the design of certain ATM/ANS equipment by holding
an organisation approval issued by the Agency in accordance with Implementing Regulation
(EU) …/… [implementing act on DPO approval], as specified in the terms of the organisation
approval.
ATM/ANS.EQMT.DEC.010 Declaration of compliance of the ATM/ANS equipment

design
An approved organisation shall submit to the Agency a dated and signed declaration of
compliance of the design of certain ATM/ANS equipment. The declaration shall contain at
least the following information:
(a) description of the design, including all the configurations;
(b) the rated performance of the product, where appropriate, either directly or by reference
to other supplementary documents;
(c) a statement of compliance certifying that the product meets the applicable specifications,
and a list of the declaration specifications;
(d) reference to relevant test reports;
(e) reference to the appropriate operation, set-up and maintenance manuals;
(f) the levels of compliance, where various levels of compliance are allowed by the
certification or declaration specifications;
(g) list of deviations, as applicable.
ATM/ANS.EQMT.DEC.015 Declaration of changes to the design of ATM/ANS

equipment
(a) An approved organisation involved in the design of ATM/ANS equipment may make
changes to the design that are within the scope of the approved organisation’s privileges.
In this case, the changed equipment shall keep its original part number.
(b) Any change to the design that is within the scope of the approved organisation’s
privileges and that is extensive enough to require a substantially complete investigation
in accordance with point ATM/ANS.EQMT.AR.C.001 to determine its compliance shall
require the assignment of a new model designation to the equipment.
ATM/ANS.EQMT.DEC.020 Record-keeping
Further to the record-keeping requirements appropriate to or associated with the management

system, all relevant design information, drawings and test reports, including inspection records
8. Appendices
for the equipment tested, shall be made available to the Agency and shall be retained in order
to provide the information necessary to ensure the continued suitability of the ATM/ANS
equipment.
ATM/ANS.EQMT.DEC.025 Manuals
The organisation involved in the design of ATM/ANS equipment, which has made the
declaration shall produce, maintain and update master copies of all manuals identified in the
declaration, and provide copies, on request, to the Agency.
ATM/ANS.EQMT.DEC.030 Maintenance instructions

(a) The design organisation which has made the declaration shall furnish at least one set of
complete maintenance instructions, comprising descriptive data and accomplishment
instructions prepared in accordance with the specifications applicable to the ATM/ANS
equipment covered by the declaration, to all known users and shall make them available
on request to any other person that is required to comply with any of the terms of these
maintenance instructions.
(b) Changes to the maintenance instructions shall be made available to all known users and
shall be made available on request to any person that is required to comply with any of
these maintenance instructions. A programme that shows how changes to the
maintenance instructions are made available to all known users shall be submitted to the
Agency upon request.
ATM/ANS.EQMT.DEC.035 Inspections performed by the Agency

Upon the Agency’s request, each organisation that has the privilege to issue a declaration in
accordance with this Regulation shall:
(a) grant the Agency access to any facility, product, part, document, record, data, process,
procedure or any other material, and allow the Agency to review any report, make any
inspection and perform or witness any test that is necessary to verify the compliance and
the continued compliance of the organisation with the applicable requirements of this
Annex;
(b) if the natural or legal person uses partners, suppliers or subcontractors, make
arrangements with them to ensure that the Agency has access to them and may investigate
as described in point (a).
8. Appendices
8.3. Appendix 3: DRAFT COMMISSION IMPLEMENTING REGULATION (EU) …/... amending

Implementing Regulation (EU) 2017/373 as regards the conformity assessment of
ATM/ANS systems and ATM/ANS constituents
DRAFT COMMISSION IMPLEMENTING REGULATION (EU) …/...
of XXX
amending Implementing Regulation (EU) 2017/373 as regards the conformity

assessment of ATM/ANS systems and ATM/ANS constituents

Whereas:
(6) Implementing Regulation (EU) 2017/373 lays down common requirements for the
provision of air traffic management and air navigation services (‘ATM/ANS’) and other
air traffic management network functions (‘ATM network functions’) for general air
traffic and their oversight.
(7) With the adoption of Commission Implementing Regulation (EU) …/… [implementing
act on DPO approval], ATM/ANS systems and ATM/ANS constituents (‘ATM/ANS
equipment’) shall be subject to certification or declaration by organisations involved in
the design and/or production of ATM/ANS equipment. To ensure the appropriate
installation, on-site testing and safe entry into service of such equipment, Implementing
Regulation (EU) 2017/373 should be amended to include the necessary requirements
on ATM/ANS providers.
(8) In order to ensure the proper implementation of this Regulation, Member States and the
affected stakeholders should be given sufficient time to adapt their procedures to the
new regulatory framework before this Regulation becomes applicable.
(9) The European Union Aviation Safety Agency has proposed measures in its Opinion
No XX/202X23 in accordance with Articles 75(2)(b) and (c) and 76(1) of Regulation
(EU) 2018/1139.
(10) Implementing Regulations (EU) 2017/373 should, therefore, be amended accordingly.
(11) The measures provided for in this Regulation are in accordance with the opinion of the
committee established by Article 127 of Regulation (EU) 2018/1139,
22
OJ L […], […], p. […].
23
https://www.easa.europa.eu/document-library/opinions
8. Appendices
Article 1
Amendments to Implementing Regulation (EU) 2017/373
Annex II to Implementing Regulation (EU) 2017/373 is amended as follows:
1. point (a) of point ATM/ANS.AR.A.020 is amended as follows:

‘(a) The competent authority shall without undue delay notify the Agency in case of
any significant problems with the implementation of the relevant provisions of
Regulation (EC) No 216/2008 and its implementing rules Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on its basis or of
Regulations (EC) No 549/2004, (EC) No 550/2004, and (EC) No 551/2004 and
Regulation (EC) No 552/2004 of the European Parliament and of the Council (1)
applicable to service providers.’;
[…]
2. point (a)(4) of ATM/ANS.AR.C.005 is amended as follows:

‘(a) Within the scope framework of point ATM/ANS.AR.B.001(a)(1), the competent
authority shall establish a process in order to verify:
[…]
(4) implementation of safety objectives, safety requirements and other safety-
related conditions identified in declarations of verification of systems,
including any relevant declaration of conformity or suitability for use of
constituents of systems issued in accordance with Regulation (EC) No
552/2004;
(4) the implementation of safety and interoperability objectives, applicable
requirements and other conditions identified in the statement of compliance
for ATM/ANS equipment; technical and performance limitations and
conditions identified in ATM/ANS equipment certificates and/or ATM/ANS
equipment declarations; and of safety measures, including ATM/ANS
equipment directives, mandated by the Agency in accordance with point
ATM/ANS.EQMT.AR.A.025 of Annex I to Delegated Regulation (EU)
…/… [delegated act on the attestation of ATM/ANS equipment];’;
3. points (c), (d) and (e) of point ATM/ANS.AR.C.050 are amended as follows:
‘(c) A level 1 finding shall be issued by the competent authority when any serious non-
compliance is detected with the applicable requirements of Regulation (EC) No
216/2008 and its implementing rules Regulation (EU) 2018/1139 and the delegated
and implementing acts adopted on its basis as well as Regulations (EC) No
549/2004, (EC) No 550/2004, and (EC) No 551/2004, and (EC) No 552/2004 and
their implementing rules, with the service ATM/ANS provider’s procedures and
manuals, with the terms andof conditions of the certificate or certificate, with the
designation act, if applicable, or with the content of a declaration which poses a
significant risk to flight safety or otherwise calls into question the service
provider’s capability to continue operations.
Level 1 findings shall include but are not be limited to:
8. Appendices
(1) the promulgationg of operational procedures and/or provision of providing a

service in a way which introduces a significant risk to flight safety;
(2) the obtainmenting or maintenancemaintaining of the validity of the service
provider’s certificate through the submission of falsified by falsification of
submitted documentary evidence;
(3) evidence of malpractice or fraudulent use of the service provider’s certificate;
(4) the lack of an accountable manager.
(d) A level 2 finding shall be issued by the competent authority when any other non-
compliance is detected with the applicable requirements of Regulation (EC) No
216/2008 and its implementing rules Regulation (EU) 2018/1139 and the delegated
and implementing acts adopted on its basis, as well as Regulations (EC) No
549/2004, (EC) No 550/2004, and (EC) No 551/2004, and (EC) No 552/2004 and
their implementing rules, with the service ATM/ANS provider’s procedures and
manuals or with the terms andof conditions of theor certificate, or with the content
of athe declaration.
(e) When a finding is detected, during oversight or by any other means, the competent
authority shall, without prejudice to any additional action required by Regulation
(EC) No 216/2008 and its implementing rules Regulation (EU) 2018/1139 and the
delegated and implementing acts adopted on its basis, as well as Regulations (EC)
No 549/2004, (EC) No 550/2004, and (EC) No 551/2004 and (EC) No 552/2004
and their implementing rules, communicate the finding to the service provider in
writing and require corrective action to address the non-compliance(s) identified.
(1) In the case of level 1 findings, the competent authority shall take immediate
and appropriate action, and may, if appropriate, limit, suspend or revoke in
whole or in part the certificate while ensuring the continuity of services
provided that safety is not compromised, and in the case of the Network
Manager, it shall inform the Commission. The measures taken shall depend
upon the extent of the finding and shall remain in force until successful
corrective action has been taken by the service ATM/ANS provider.
(2) In the case of level 2 findings, the competent authority shall:
(i) grant the service provider a corrective action implementation period
included in an action plan appropriate to the nature of the finding;
(ii) assess the corrective action and implementation plan proposed by the
service provider, and, if the assessment concludes that they are
sufficient to address the non-compliance(s), accept them.
(3) In the case of level 2 findings, where the service provider fails to submit a
corrective action plan that is acceptable to the competent authority in the light
of the finding, or where the service provider fails to perform the corrective
action within the time period accepted or extended by the competent
authority, the finding may be raised to a level 1 finding, and action shall be
taken as laid down in point (1).
(f) Where the competent authority detects that ATM/ANS equipment is not integrated
into the ATM/ANS functional system as per point (x) of point
ATM/ANS.OR.A.045, it shall, with due regard to the need to ensure the safety and
continuity of operations, take all measures necessary to restrict the area of
application of the ATM/ANS equipment concerned or prohibit its use by the
ATM/ANS providers under its oversight.
8. Appendices
(g) For those cases that do not requireing level 1 and 2 findings, the competent
authority may issue observations.’;
4. the following points (g) and (h) are added to point ATM/ANS.OR.A.045:
‘(g) Before integrating ATM/ANS equipment into the ATM/ANS functional system,
the ATM/ANS provider shall ensure that:
(1) new or modified ATM/ANS equipment is certified by the Agency in
accordance with Delegated Regulation (EU) …/… [delegated act on the
attestation of ATM/ANS equipment] and manufactured by an approved
ATM/ANS equipment organisation pursuant to Implementing Regulation
(EU) …/… [implementing regulation on DPO approval]; or
(2) new or modified ATM/ANS equipment is declared by an approved design
organisation pursuant to Delegated Regulation (EU) …/… [delegated act on
the attestation of ATM/ANS equipment] and manufactured by an approved
ATM/ANS equipment organisation pursuant to Implementing Regulation
(EU) …/… [implementing act DPO approval]; or
(3) by way of derogation from points (1) and (2), when the ATM/ANS
equipment is neither subject to certification nor to declaration pursuant to
Delegated Regulation (EU) …/… [delegated act on the attestation of
ATM/ANS equipment], the ATM/ANS provider shall make a statement of
compliance for the ATM/ANS equipment to declare its compliance with the
applicable technical standards established in accordance with Article 6(1) of
Delegated Regulation (EU) …/… [delegated act on the attestation of
ATM/ANS equipment]; and
(4) the particular ATM/ANS equipment has been verified to comply with the
equipment manufacturer’s specifications, including installation and on-site
test(s).
(h) When the ATM/ANS provider puts the ATM/ANS equipment into service, it shall
ensure that the ATM/ANS equipment, or the modified one, is deployed according
to the conditions of use, as well as to any prescribed limitations, and meets all the
applicable requirements that stem from the safety assessment or the safety support
assessment.’.
Article 2
Entry into force
Done at Brussels,
For the Commission

The President
[…]

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European Union Aviation Safety Agency

Notice of Proposed Amendment 2022-09

Establishment of a regulatory framework on the

EASA rulemaking procedure milestones

Start Public consultation Proposal to the Adoption by the Decision

14.2.2020 16.8.2022 2022/Q3 2023/Q3 2023/Q3

4.5.2. Environmental impact ..................................................................................................... 32

1. About this NPA

1.2. How to comment on this NPA

1.3. The next steps

2. In summary — why and what

2.2. What we want to achieve — objectives

2.3. How we want to achieve it — overview of the proposed implementing and

— identification of the functional requirements for ATM/ANS equipment;

— definition of the technical requirements;

11 For further details, please refer to Section 2.3.2.

— identification of the scope of changes to the design and production of ATM/ANS

— the design and production, and changes, including:

• ensuring compliance with the applicable specifications,

• an independent checking function, and

• production control procedures;

— the verification of the acceptability of GE and of (any) tasks performed by contracted

— coordination within departments and between departments.

equipment based on detailed declaration specifications adopted by EASA. It is proposed that

2.3.1.3 Draft implementing act amending Implementing Regulation (EU) 2017/373

2.3.2. Maintenance activities

2.3.3. Transitional provisions

2.3.4. Other associated deliverables

No 552/2004, Regulation (EC) 1032/200614, Regulation (EC) No 262/200915, Implementing

3. Proposed implementing and delegated acts

4. Impact assessment (IA)

Please refer to Section 2.1.

4.1.1. Safety risk assessment

4.1.2. Who is affected

4.1.3. How could the issue evolve

4.2. What we want to achieve — objectives

Please refer to Section 2.2.

4.3. How we want to achieve it — options

Option Short title Description

0 Baseline Do not implement the Basic Regulation.

1 Introduction of Introduction of the ATM/ANS equipment attestation scheme with

— central ATFM systems;

4.4. Methodology and data

4.4.1. Methodology applied

The MCA key steps in this IA include the following:

4.5. What are the impacts

4.5.1. Safety impact

17 Community specifications (europa.eu)

Table 3: Safety impacts

Option Short title Description Score

0 Baseline (= do Do not implement the Basic Regulation. 0

1 Introduction of the Improved ability to introduce safety enablers. +4

4.5.2. Environmental impact

4.5.3. Social impact

4.5.4. Economic impact

PROMOTE INTERNAL AND EXTERNAL MARKET OPPORTUNITIES

certification/declaration of certain ATM/ANS equipment by its manufacturers, it is anticipated that

Table 4: Economic impact

Option Short title Description Score

0 Baseline (= do No change to the current practice 0

1 Introduction of the While the additional cost for ATM/ANS equipment +6

Stakeholders are invited to provide:

4.5.5. Proportionality issues